Dental Devices; Effective Date of Requirement for Premarket Approval of Endodontic Dry Heat Sterilizer

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 872

[Docket No. 95N-0033]

Dental Devices; Effective Date of Requirement for Premarket

Approval of Endodontic Dry Heat Sterilizer

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; opportunity to request a change in

classification.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to require

the filing of a premarket approval application (PMA) or a notice of

completion of a product development protocol (PDP) for the endodontic

dry heat sterilizer, a medical device. The agency also is summarizing

its proposed findings regarding the degree of risk of illness or injury

designed to be eliminated or reduced by requiring the device to meet

the statute's approval requirements, and the benefits to the public

from use of the device. In addition, FDA is announcing the opportunity

for interested persons to request the agency to change the

classification of the device based on new information.

DATES: Written comments by September 5, 1995; requests for a change in

classification by June 22, 1995. FDA intends that, if a final rule

based on this proposed rule is issued, PMA's will be required to be

submitted within 90 days of the effective date of the final rule.

ADDRESSES: Submit written comments or requests for a change in

classification to the Dockets Management Branch (HFA-305), Food and

Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices

and Radiological Health (HFZ-84), Food and Drug Administration, 2094

Gaither Rd., Rockville, MD 20850, 301-594-4765.

SUPPLEMENTARY INFORMATION:

I. Background

Section 513 of the Federal Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 360c) requires the classification of medical devices into

one of three regulatory classes: Class I (general controls), class II

(special controls), and class III (premarket approval). Generally,

devices that were on the market before May 28, 1976, the date of

enactment of the Medical Device Amendments of 1976 (the amendments)

(Pub. L. 94-295), and devices marketed on or after that date that are

substantially equivalent to such devices, have been classified by FDA.

For the sake of convenience, this preamble refers to both the devices

that were on the market before May 28, 1976, and the substantially

equivalent devices that were marketed on or after that date as

``preamendments devices.''

Section 515(b)(1) of the act (21 U.S.C. 360e(b)(1)) establishes the

requirement that a preamendments device that FDA has classified into

class III is subject to premarket approval. A preamendments class III

device may be commercially distributed without an approved PMA or

notice of completion of a PDP until 90 days after FDA issues a final

rule requiring premarket approval for the device, or 30 months after

final classification of the device under section 513 of the act,

whichever is later. Also, a preamendments device, subject to the

rulemaking procedure under section 515(b) of the act, is not required

to have an approved investigational device exemption (IDE) (21 CFR part

812) contemporaneous with its interstate distribution until the date

identified by FDA in the final rule requiring the submission of a PMA

for the device.

Section 515(b)(2)(A) of the act provides that a proceeding to issue

a final rule to require premarket approval shall be initiated by

publication of a notice of proposed rulemaking containing: (1) The

proposed rule; (2) proposed findings with respect to the degree of risk

of illness or injury designed to be eliminated or reduced by requiring

the device to have an approved PMA or a declared completed PDP and the

benefit to the public from the use of the device; (3) an opportunity

for the submission of comments on the proposed rule and the proposed

findings; and (4) an opportunity to request a change in the

classification of the device based on new information relevant to the

classification of the device.

Section 515(b)(2)(B) of the act provides that if FDA receives a

request for a change in the classification of the device within 15 days

of the publication of the notice, FDA shall, within 60 days of the

publication of the notice, consult with the appropriate FDA advisory

committee and publish a notice denying the request for change of

classification or announcing its intent to initiate a proceeding to

reclassify the device under section 513(e) of the act. If FDA does not

initiate such a proceeding, section 515(b)(3) of the act provides that

FDA shall, after the close of the [[Page 30033]] comment period on the

proposed rule and consideration of any comments received, issue a final

rule to require premarket approval, or publish a notice terminating the

proceeding. If FDA terminates the proceeding, FDA is required to

initiate reclassification of the device under section 513(e) of the

act, unless the reason for termination is that the device is a banned

device under section 516 of the act (21 U.S.C. 360f).

If a proposed rule to require premarket approval for a

preamendments device is made final, section 501(f)(2)(B) of the act (21

U.S.C. 351(f)(2)(B)) requires that a PMA or a notice of completion of a

PDP for any such device be filed within 90 days of the date of issuance

of the final rule or 30 months after final classification of the device

under section 513 of the act, whichever is later. If a PMA or a notice

of completion of a PDP is not filed by the later of the two dates,

commercial distribution of the device is required to cease. The device

may, however, be distributed for investigational use if the

manufacturer, importer, or other sponsor of the device complies with

the IDE regulations. If a PMA or a notice of completion of a PDP is not

filed by the later of the two dates, and no IDE is in effect, the

device is deemed to be adulterated within the meaning of section

501(f)(1)(A) of the act, and subject to seizure and condemnation under

section 304 of the act (21 U.S.C. 334) if its distribution continues.

Shipment of the device in interstate commerce will be subject to

injunction under section 302 of the act (21 U.S.C. 332), and the

individuals responsible for such shipment will be subject to

prosecution under section 303 of the act (21 U.S.C. 333). FDA has in

the past requested that manufacturers take action to prevent the

further use of devices for which no PMA has been filed and may

determine that such a request is appropriate for endodontic dry heat

sterilizers.

The act does not permit an extension of the 90-day period after

issuance of a final rule within which an application or a notice is

required to be filed. The House Report on the amendments states that:

the thirty month `grace period' afforded after classification of

a device into class III * * * is sufficient time for manufacturers

and importers to develop the data and conduct the investigations

necessary to support an application for premarket approval.

(H. Rept. 94-853, 94th Cong., 2d sess. 42 (1976).)

A. Classification of Endodontic Dry Heat Sterilizers

In the Federal Register of August 12, 1987 (52 FR 30082), FDA

issued a final rule (Sec. 872.6730 (21 CFR 872.6730)) classifying the

endodontic dry heat sterilizer into class III. The preamble to the

proposal to classify the device published in the Federal Register of

December 30, 1980 (45 FR 86155), included the recommendation of the

Dental Device Classification Panel (the panel), of the Medical Devices

Advisory Committee, an FDA advisory committee, regarding the

classification of the device.

The panel recommended that the device be in class III (premarket

approval) because the device presented an unreasonable risk of illness

or injury. According to the panel, the devices failed to sterilize

adequately various endodontic and dental instruments. The panel felt

that the failures could be the result of: (1) The device not reaching

and maintaining an adequate temperature because of a faulty thermostat

or (2) the result of unequal heat distribution by the glass beads

throughout the well despite sufficient heat. The panel believed that it

was not possible to establish an adequate performance standard for the

device because satisfactory performance had never been demonstrated.

The panel recommended the device to be subject to premarket approval to

assure that manufacturers of the device demonstrate satisfactory

performance and that further study was necessary to determine the

causes of the device's ineffectiveness.

FDA agreed with the panel's recommendation that endodontic dry heat

sterilizers be classified into class III. FDA believed that there was

an unreasonable risk of illness or injury because of the potential

failure of the device to sterilize dental instruments adequately. FDA

believed that there was inadequate information to determine if general

controls or a performance standard would provide reasonable assurance

of safety and effectiveness.

B. Dates New Requirements Apply

In accordance with section 515(b) of the act, FDA is proposing to

require that a PMA or a notice of completion of a PDP be filed with the

agency for the endodontic dry heat sterilizer within 90 days after

issuance of any final rule based on this proposal. An applicant whose

device was legally in commercial distribution before May 28, 1976, or

has been found by FDA to be substantially equivalent to such a device,

will be permitted to continue marketing the endodontic dry heat

sterilizer during FDA's review of the PMA or notice of completion of

the PDP. FDA intends to review any PMA for the device within 180 days,

and any notice of completion of a PDP for the device within 90 days of

the date of filing. FDA cautions that, under section 515(d)(1)(B)(i) of

the act, FDA may not enter into an agreement to extend the review

period for a PMA beyond 180 days unless the agency finds that `` * * *

the continued availability of the device is necessary for the public

health.''

FDA intends that, under Sec. 812.2(d), the preamble to any final

rule based on this proposal will state that, as of the date on which a

PMA or a notice of completion of a PDP is required to be filed, the

exemptions in Sec. 812.2 (c)(1) and (c)(2) from the requirements of the

IDE regulations for preamendments class III devices will cease to apply

to any endodontic dry heat sterilizer which is: (1) Not legally on the

market on or before that date; (2) legally on the market on or before

that date but for which a PMA or notice of completion of a PDP is not

filed by that date; or (3) for which PMA approval has been denied or

withdrawn.

If a PMA or a notice of completion of a PDP for the endodontic dry

heat sterilizer is not filed with FDA within 90 days after the date of

issuance of any final rule requiring premarket approval for the device,

commercial distribution of the device must cease. The device may be

distributed for investigational use only if the requirements of the IDE

regulations are met. FDA would not consider an investigation of an

endodontic glass bead sterilizer to pose a significant risk as defined

in the IDE regulation provided that instruments processed in the device

are terminally sterilized by a sterilization process which can be

biologically monitored, such as steam, ethylene oxide, or dry heat. If

the investigation cannot be so designed, the investigation would

constitute a significant risk. The requirements for significant risk

devices include submitting an IDE application to FDA for its review and

approval. An approved IDE is required to be in effect before an

investigation of the device may be initiated or continued. FDA,

therefore, cautions that IDE applications should be submitted to FDA at

least 30 days before the end of the 90-day period after the final rule

is published to avoid interrupting investigations.

C. Description of Device

Endodontic dry heat sterilizers are small electrically heated dry

heat sterilizers with a central well containing a heat transfer medium.

The types of [[Page 30034]] heat transfer media used in these units

have included glass beads, molten metal, metal beads, and salt. The

instruments which are to be sterilized are inserted directly into the

heat transfer medium. The units are defined in Sec. 872.6730 as devices

used to sterilize endodontic and other dental instruments by the

application of dry heat which is supplied by the glass beads which have

been heated by electricity.

The proposed rule to require premarket approval of the endodontic

dry heat sterilizer applies to devices that were being commercially

distributed before May 28, 1976, and to devices that were introduced

into commercial distribution since that date which have been found to

be substantially equivalent to predicate endodontic dry heat

sterilizers.

D. Proposed Findings With Respect to Risks and Benefits

As required by section 515(b) of the act, FDA is publishing its

proposed findings regarding: (1) The degree of risk of illness or

injury designed to be eliminated or reduced by requiring endodontic dry

heat sterilizers to have an approved PMA or a declared completed PDP;

and (2) the benefits to the public from the use of the device.

E. Risk Factors

The panel identified the primary risk to health as infection by

stating that ``The inability of the device to sterilize adequately

endodontic and other dental instruments may lead to transmission of

microorganisms among patients and subsequent spread of infection.''

A review of the literature on endodontic dry heat sterilizers has

identified the following problems associated with the use of these

devices which contribute to the inability of endodontic dry heat

sterilizers to sterilize instruments, including general medical

instruments.

1. Temperature Variation Within the Well

There are many reports in the literature describing the temperature

variation found within the wells of glass bead sterilizers (Refs. 2, 3,

4, 7, 10, and 11). Engelhardt et al. (Ref. 4) measured the temperature

distribution in four brands of glass bead sterilizers at two different

sites from the center and at six different depths in the well. He

reported that the temperature within the well varied significantly

depending upon location. The temperature was highest closest to the

wall and midway down from the surface (Ref. 4). Corner also reported

that near the periphery of the well the temperature varied by as much

as 10 deg.C over time (Ref. 5). According to Ingle, glass bead

sterilizers should not be used as a substitute for dry heat convection

or steam sterilizers because of the temperature variations (Ref. 7).

2. Lack of Methods to Monitor the Recommended Exposure Times for

Sterilization of the Instruments

The manufacturers' recommended exposure times for sterilization of

instruments vary from as short as 2 seconds to 45 seconds for

sterilizers whose purported operating temperatures are from 218 deg.C

to 260 deg.C. However, location of the instruments in the well, the

size and mass of the instruments, the number of instruments, and the

shape of the instruments must be factored into the amount of time

required for sterilization. Larger instruments composed of more metal

take more time to heat than smaller instruments. Koehler reported that

the time required to raise an instrument's temperature was dependent

upon its size. Small instruments such as root canal files heated

rapidly, while large instruments such as cotton pliers never reached

the specified operating temperature (Ref. 6). Corner reported that

instruments such as forceps, scalpels, spatulas, and scissors

sterilized in rapid succession caused the temperature in the well to

drop an average of 7 deg.C for each instrument and that it took 15

minutes for the temperature of the well to recover (Ref. 2). Smith

reported sterilization times of 15 seconds to kill orthodontic bands

contaminated with Staphylococcus albus and 45 seconds for bands

contaminated with Bacillus subtilis spores; but if five bands were

sterilized simultaneously, then the sterilization times doubled (Ref.

10). Fahid reported that a No. 60 file, which was the largest file

tested in the study, was the most difficult to sterilize. The

difficulty was attributed to two factors: the large mass of the file,

and the air trapped in the deep trough since air is a poor heat

conductor (Ref. 5). Engelhardt described sterilization times for

endodontic instruments ranging from 15 to more than 100 seconds in

glass bead sterilizers, and in some cases, the 100 seconds were not

sufficient to achieve sterilization (Ref. 4). Schutt et al. found that

it took 60 seconds to sterilize dental burs. He also emphasized that

the temperature at the depth of the immersion of the burs should be

measured and that the minimum temperature should be at least 175 deg.C

at 2 millimeters (mm) below the surface and 240 deg.C at 15 mm below

the surface (Ref. 9). It has been reported in the literature that glass

bead sterilizers have been shown to be effective only with small

instruments that can be imbedded into the heat transfer media and that

their effectiveness has not been demonstrated for instruments of larger

bulk. The insertion of large instruments would reduce the temperature

of the glass beads below the minimum temperature required for

sterilization (Ref. 1). Heat conduction in a large, partially imbedded

device would be variable.

Precleaning of the instruments before insertion into the glass bead

sterilizer is critical to the effectiveness of the device. Engelhardt

demonstrated that if endodontic instruments were contaminated with a

protein load (blood), the time required for sterilization was more than

doubled. Such adverse conditions can easily be found in infected or

gangrenous pulp. Spores, which are more resistant to sterilization

processes than vegetative organisms, have been found in the oral cavity

and cultured from pulp material (Ref. 4).

3. Lack of Methods to Monitor the Performance/Sterilization Efficacy of

the Device

There are no identified methods for the routine monitoring of the

sterilization efficacy of the endodontic dry heat sterilizer such as

the ones which exist with the traditional sterilization methods, i.e.,

steam autoclaves, hot air dry heat sterilizers, or ethylene oxide

sterilizers. Chemical and biological indicators are available for

routine monitoring of the efficacy of the cycle parameters and for the

validation of the process specifications for these traditional

sterilizers. The data in the literature, as noted above, suggest that

the user can not be assured that instruments inserted into an

endodontic dry heat sterilizer will be reliably exposed to the minimum

cycle parameters required for sterilization, i.e., exposure of the

device to a set temperature for a specified time.

4. Variability of the Warm-up Times for Glass Bead Sterilizers

Reported warm-up times for these devices range from 15 minutes to

50 minutes with the average of 15-20 minutes. However, Corner reported

that it took up to 30 minutes for the temperature of the glass beads to

stabilize even though the manufacturer claimed that the device reached

operating temperature within 10 minutes (Ref. 2). [[Page 30035]]

5. Maintenance of Sterility After Removal From the Device

The instructions for use for most of the devices do not instruct

the user on the proper procedure to remove instruments from the device,

and on how to maintain sterility of the instruments or the processed

portion of the instrument during the cool down period. There also

exists the possibility that the heat transfer medium could serve as a

source of contamination between patients. Because of the reported

temperature gradients within the wells, there exists the possibility

that heat resistant microorganisms could survive in the cooler regions

near the top of the well and contaminate the instruments used upon the

next patient as they are removed from the well. Furthermore, because

endodontic dry heat sterilizers only process that portion of the

instrument which has been inserted into the glass beads, there is the

potential of contaminating a sterile field with a device which had not

been properly processed.

6. Possibility of the Heat Transfer Medium Remaining Upon The Devices

Occasionally the heat transfer media has been observed to adhere to

wet instruments. If the particles are not detected before the devices

are inserted into the site, then they could cause blockage of the wound

site or other adverse effects. This would cause significant problems if

the heat transfer media were glass beads or molten metal (Ref. 1).

F. Benefit of the Devices

The endodontic dry heat sterilizer could be used to decontaminate

endodontic instruments during a procedure on a single patient provided

the instruments are properly cleaned to remove organic debris before

insertion into the unit. In theory the number of microorganisms that

would be introduced into the same site or into a new site on the same

patient during a single procedure would be reduced. Once the procedure

is over, the instruments should be processed using traditional methods

of decontamination and sterilization before use in the next patient.

G. Need for Information for Risk/Benefit Assessment of the Device

The data in the literature indicate the lack of uniform

sterilization parameters among the various glass bead sterilizers which

have been marketed. Because of the temperature variation found within

the wells of glass bead sterilizers, exposure of an instrument to an

adequate sterilizing temperature is difficult to determine and must be

confirmed independently for each instrument. Also determination of the

sterilization exposure time is dependent upon instrument size and mass.

As Koehler noted, some instruments never reach the appropriate

temperature because of their size and mass (Ref. 6); and, as noted in

the American Dental Association's ``Accepted Dental Therapeutics,''

40th ed., endodontic dry heat sterilizers are not appropriate for large

bulk instruments (Ref. 1).

Review of the claims being made for these devices suggests that

manufacturers are expanding the claims beyond those originally defined

in Sec. 872.6730. The claims have been expanded to include the

sterilization of general medical instruments and electrolysis and

acupuncture needles, and to devices not regulated by FDA such as

manicurist's instruments. The claims imply that these devices can be

used as a substitute for the traditional methods of sterilization.

Scarlett noted that endodontic dry heat sterilizers are not

sterilizers, but are decontaminating devices and that they should not

be used to sterilize instruments between patients (Ref. 8). No system

exists for (1) Monitoring the exposure of the instrument to

sterilization conditions, or (2) demonstrating that the sterilization

exposure parameters have been achieved within the well. Only the

portion of the instrument which is inserted into the heat transfer

medium has the potential of being sterilized; the portion which is not

inserted into the glass beads is not sterilized. The use of endodontic

dry heat sterilizers with general medical instruments and with the

implication as a substitute sterilization method raises serious safety

and effectiveness questions which the manufacturers of these devices

have not adequately addressed. There is the serious risk of infection

through the use of inadequately processed instruments.

FDA believes that sufficient information may exist regarding the

risks and benefits associated with the device, but the information must

be assembled in such a way as to enable FDA to determine if the

information provides reasonable assurance of the safety and

effectiveness of the device for its intended use as defined in 21 CFR

860.7.

FDA classified the endodontic dry heat sterilizer into class III

because it determined that insufficient information existed to

determine that general controls would provide reasonable assurance of

the safety and effectiveness of the device or to establish a

performance standard to provide such assurance. FDA has determined that

the special controls that may now be applied to class II devices under

the Safe Medical Devices Act of 1990 also would not provide such

assurance. FDA has weighed the probable risks and benefits to the

public health from the use of the device and believes that the

literature reports and other information discussed above present

evidence of significant risks associated with use of the device. These

risks must be addressed by the manufacturers of endodontic dry heat

sterilizers. FDA believes that the endodontic dry heat should undergo

premarket approval to establish effectiveness and to determine whether

the benefits to the patient are sufficient to outweigh any risk.

II. PMA Requirements

A PMA for this device must include the information required by

section 515(c)(1) of the act. Such a PMA should also include a detailed

discussion of the risks identified above, as well as a discussion of

the effectiveness of the device for which premarket approval is sought.

A PMA should include valid scientific evidence obtained from well-

controlled studies, with detailed data, in order to provide reasonable

assurance of the safety and effectiveness of the endodontic dry heat

sterilizer for its intended use. The data must include the following

information:

a. A general description of the sterilizer including its

specifications, process parameters and process monitors;

b. An overview of the sterilization process with accompanying

charts, graphs, or other visuals explaining all parameters;

c. A description of any test packs used in validating the

performance of the endodontic dry heat sterilizer and in routine

monitoring of the device;

d. Physical tests which demonstrate that the sterilizer achieves

and maintains the physical process lethality conditions within

specifications. The testing should describe how the process parameters

and specifications were determined;

e. The microbiological performance tests must demonstrate that the

device can sterilize to an acceptable sterilization assurance level all

medical products identified in the labeling when used in accordance

with the directions for use. The tests should be consistent with those

used to validate sterilization processes including simulated and actual

use tests;

f. Material compatibility tests must show that the medical devices

identified in the labeling are compatible with the

[[Page 30036]] sterilization process of the endodontic dry heat

sterilizer; and

g. Final qualification tests from at least three consecutive runs

under worst case loading conditions as indicated in the labeling.

Additional information about the validation of sterilization

processes can be found in: ``Guidance on Premarket Notification

(510(k)) Submissions for Sterilizers Intended for Use in Health Care

Facilities'' (available upon request from the Center for Devices and

Radiological Health, Division of Small Manufacturers Assistance (HFZ-

220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD

20850); the American Association of Medical Instrumentation's (AAMI)

voluntary standards describing the validation requirements for

sterilization processes; and the publication entitled ``Sterile Medical

Devices, A GMP Workshop Manual, 4th Ed., HHS Publication (FDA) 84-4147.

The PMA should contain a detailed discussion with supporting

simulated- and in-use studies, as described in the above guidance, of:

(1) All risks that have been identified in this proposed rule; and (2)

the effectiveness of the specific endodontic dry heat sterilizer that

is the subject of the application. In addition, the submission should

contain all data and information on: (1) Risks known to the applicant

that have not been identified in this proposed rule; (2) summaries of

all existing simulated- and in-use data from investigations on the

safety and effectiveness of the device for which premarket approval is

sought; and (3) the results of simulated- and in-use studies conducted

by or for the applicant. Applicants should submit any PMA in accordance

with the FDA's ``Guideline for the Arrangement and Content of a PMA

Application.'' The guideline is available from the Center for Devices

and Radiological Health, Division of Small Manufacturers Assistance

(address above).

III. Comments

Interested persons may, on or before September 5, 1995, submit to

the Dockets Management Branch (address above) written comments

regarding this proposal. Two copies of any comments are to be

submitted, except that individuals may submit one copy. Comments or

requests are to be identified with the docket number found in brackets

in the heading of this document. Received comments and requests may be

seen in the office above between 9 a.m. and 4 p.m., Monday through

Friday.

IV. Opportunity to Reguest a Change in Classification

Before requiring the filing of a PMA or a notice of completion of a

PDP for a device, FDA is required by section 515 (b)(2)(A)(i) through

(b)(2)(A)(iv) of the act and 21 CFR 860.132 to provide an opportunity

for interested persons to request a change in the classification of the

device based on new information relevant to its classification. Any

proceeding to reclassify the device will be under the authority of

section 513(e) of the act.

A request for a change in the classification of the endodontic dry

heat sterilizer is to be in the form of a reclassification petition

containing the information required by Sec. 860.123 (21 CFR 860.123),

including new information relevant to the classification of the device,

and shall, under section 515(b)(2)(B) of the act, be submitted by June

22, 1995.

The agency advises that, to ensure timely filing of any such

petition, any request should be submitted to the Dockets Management

Branch (address above) and not to the address provided in

Sec. 860.123(b)(1). If a timely request for a change in the

classification of the endodontic dry heat sterilizer is submitted, the

agency will, by August 7, 1995, after consultation with the appropriate

FDA advisory committee and by an order published in the Federal

Register, either deny the request or give notice of its intent to

initiate a change in the classification of the device in accordance

with section 513(e) of the act and 21 CFR 860.130 of the regulations.

V. References

The following references have been placed on display in the Dockets

Management Branch (address above) and may be seen by interested persons

between 9 a.m. and 4 p.m., Monday through Friday.

1. American Dental Association, ``Accepted Dental Therapeutics,''

40th ed., pp. 138-139, Chicago, IL, 1984.

2. Corner, G. A., ``An Assessment of the Performance of a Glass Bead

Sterilizer,'' Journal of Hospital Infection, 10:308-311, 1987.

3. Dayoub, M. B., and M. J. Devine, ``Endodontic Dry-Heat Sterilizer

Effectiveness,'' Journal of Endodontics, 2:343-344, 1976.

4. Engelhardt, M. P., L. Grun, and H. Dahl, ``Factors Affecting

Sterilization in Glass Bead Sterilizers,'' Journal of Endodontics,

10:454-470, 1984.

5. Fahid, A., and J. F. Tainter, ``The Influence of File Size,

Cleaning, and Time on the Effectiveness of Bead Sterilizers,'' Oral

Surgery, 58:443-445, 1984.

6. Koehler, H. M., and J. J. Hefferren, ``Time-Temperature Relations

of Dental Instruments Heated in Root-Canal Instrument Sterilizers,''

Journal of Dental Research, 41:182-195, 1962.

7. Ingle, J. I., Endodontics, 3d Ed., Philadelphia, Lea & Febiger,

pp. 615-616.

8. Jakush, J., ``Infection Control Procedures and Products: Cautions

and Common Sense,'' Journal of The American Dental Association,

117:293-301, 1988.

9. Schutt, R. W., and W. J. Starsiak, ``Glass Bead Sterilization of

Surgical Dental Burs,'' International Journal of Oral and

Maxillofacial Surgery, 19:250-251, 1990.

10. Smith, G. E., ``Glass Bead Sterilization of Orthodontic Bands,''

American Journal of Orthodontics Dentofacial Orthopedics, 90:243-

249, 1986.

11. Windeler, A. S., and R. G. Walter, ``The Sporicidal Activity of

Glass Beads Sterilizers,'' Journal of Endodontics, 1:273-275, 1975.

VI. Environmental Impact

The agency has determined under 21 CFR 25.24(a)(8) that this action

is of a type that does not individually or cumulatively have a

significant effect on the human environment. Therefore, neither an

environmental assessment nor an environmental impact statement is

required.

VII. Analysis of Impacts

FDA has examined the impacts of the proposed rule under Executive

Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).

Executive Order 12866 directs agencies to assess all costs and benefits

of available regulatory alternatives and, when regulation is necessary,

to select regulatory approaches that maximize net benefits (including

potential economic, environmental, public health and safety, and other

advantages; distributive impacts; and equity). The agency believes that

this proposed rule is consistent with the regulatory philosophy and

principles identified in the Executive Order. In addition, the proposed

rule is not a significant regulatory action as defined by the Executive

Order and so is not subject to review under the Executive Order.

The Regulatory Flexibility Act requires agencies to analyze

regulatory options that would minimize any significant impact of a rule

on small entities. Because PMA's for this device could have been

required by FDA as early as February 12, 1990, and because firms that

distributed this device prior to May 28, 1976, or whose device has been

found by FDA to be substantially equivalent will be permitted to

continue marketing the endodontic dry heat sterilizer during FDA's

review of the PMA or notice of completion of the [[Page 30037]] PDP,

the agency certifies that the proposed rule will not have a significant

economic impact on a substantial number of small entities.

Therefore, under the Regulatory Flexibility Act, no further

analysis is required.

List of Subjects in 21 CFR Part 872

Medical devices.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under

the authority delegated to the Commissioner of Food and Drugs, it is

proposed that 21 CFR part 872 be amended as follows:

PART 872--DENTAL DEVICES

1. The authority citation for 21 CFR part 872 is revised to read as

follows:

Authority: Secs. 501, 510, 513, 515, 520, 522, 701 of the

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c,

360e, 360j, 360l, 371).

2. Section 872.6730 is amended by revising paragraph (c) to read as

follows:

Sec. 872.6730

Endodontic dry heat sterilizer.

* * * * *

(c) Date premarket approval application (PMA) or notice of

completion of product development protocol (PDP) is required. A PMA or

a notice of completion of a PDP is required to be filed with the Food

and Drug Administration on or before (90 days after the effective date

of a final rule based on this proposed rule), for any endodontic dry

heat sterilizer that was in commercial distribution before May 28,

1976, or that has on or before (90 days after the effective date of a

final rule based on this proposed rule), been found to be substantially

equivalent to the endodontic dry heat sterilizer that was in commercial

distribution before May 28, 1976. Any other endodontic dry heat

sterilizer shall have an approved PMA or declared completed PDP in

effect before being placed in commercial distribution.

Dated: May 24, 1995.

D. B. Burlington,

Director, Center for Devices and Radiological Health.

[FR Doc. 95-13831 Filed 6-6-95; 8:45 am]

BILLING CODE 4160-01-P