IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE by GLENWOOD, LLC.

The Impact Air 45 Handpiece for Endodontic Use is an air-powered dental handpiece intended for use in apicoectomy (root canal drainage) and other endodontic procedures for which a conventional handpiece would be used. The handpiece is intended to provide a better work environment than a conventional high-speed, air-powered handpiece in that (1) it is designed so that air is not directed onto the area of the bur and (2) it is designed with a 45-degree back-angled head shank to facilitate access.

The device is intended for use with all friction-grip burs, including surgical length burs, that conform to I.S.O. and A.D.A. shank diameter standards (0.0626 to 0.0630 inches). The recommended operating air pressure is between 32 and 40 pounds per square inch ("psi"), which results in high-speed bur rotation (approximately 400,000 to 500,000 revolutions per minute ("rpm")). The device includes a water line that directs water onto the spinning bur, which forms a cooling mist and also helps irrigate the working area. The use of sterile water is recommended. One model of the device also includes a fiberoptic bundle that directs light onto the working area.

The device may be connected to a standard compressed air source found in virtually all dental units. The use of filtered air is recommended. The air supply enters the device through a tube in the handle and turns the turbine, which is in the head of the device, thus spinning the bur. The air exits the device principally through an air exhaust tube in the handle. A smaller portion of the air exits through the top of the head of the device. Virtually no air exits from the front of the head into the area of the bur.

The Impact Air 45 can be sterilized by autoclave when processed for 35 minutes at 250 degrees. Data indicate that after 250 sterilization cycles the handpiece continues to function appropriately.

AI/ML Overview

The provided text is a 510(k) summary for the Impact Air 45 Handpiece for Endodontic Use. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with defined performance metrics.

Therefore, many of the requested categories (such as sample size, expert qualifications, and detailed performance metrics) are not explicitly stated in this type of regulatory submission. The primary "study" described is a testing of sterilization cycles.

Here's the information that can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Sterilization Durability: Continue to function appropriately after sterilization cycles.	After 250 sterilization cycles, the handpiece continues to function appropriately.
Material/Design Conformance: Use with ISO/ADA standard friction-grip burs (0.0626 to 0.0630 inches).	Intended for use with all friction-grip burs, including surgical length burs, that conform to I.S.O. and A.D.A. shank diameter standards. This indicates compliance with the criteria.
Operating Conditions: Recommended operating air pressure (32-40 psi).	The recommended operating air pressure is between 32 and 40 pounds per square inch ("psi"). This indicates compliance with the criteria.
Rotational Speed: High-speed bur rotation (400,000 to 500,000 rpm).	Results in high-speed bur rotation (approximately 400,000 to 500,000 revolutions per minute ("rpm")). This indicates compliance with the criteria.
Air Direction: Air not directed onto the area of the bur.	Designed so that air is not directed onto the area of the bur. Virtually no air exits from the front of the head into the area of the bur. This indicates compliance with the criteria.
Access: 45-degree back-angled head shank to facilitate access.	Designed with a 45-degree back-angled head shank to facilitate access. This indicates compliance with the criteria.
Cooling/Irrigation: Water line directs water onto the spinning bur.	Includes a water line that directs water onto the spinning bur, which forms a cooling mist and also helps irrigate the working area. This indicates compliance with the criteria.
Sterilization Method: Able to be sterilized by autoclave.	The Impact Air 45 can be sterilized by autoclave when processed for 35 minutes at 250 degrees. This indicates compliance with the criteria.

2. Sample size used for the test set and the data provenance

Sample Size for Sterilization Testing: Not explicitly stated, however, the statement "Data indicate that after 250 sterilization cycles the handpiece continues to function appropriately" implies at least one device was tested and subjected to 250 cycles. The exact number of units tested is not provided.
Data Provenance: Not specified, but likely internal testing by the manufacturer (Palisades Dental A Division of Glenwood, L.L.C.) given the nature of the submission. The country of origin for the data is not mentioned, but the manufacturer is based in Tenafly, NJ, USA. The testing would be considered "prospective" for the specific test conducted (sterilization cycles).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable for this type of device and submission. The "ground truth" here is objective physical performance (e.g., functioning after sterilization, bur rotation speed, air pressure). Expert consensus is not relevant for these technical specifications.

4. Adjudication method for the test set

Not applicable. Performance metrics for mechanical devices generally do not require adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a dental handpiece, not an AI-powered diagnostic or assistive tool for human readers/clinicians.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A (See point 5). This is a mechanical device, not an algorithm. The "standalone" performance here refers to the device's inherent mechanical function.

7. The type of ground truth used

Objective Device Performance Data: For the sterilization test, the ground truth is simply whether the device "continues to function appropriately" after the specified number of cycles. For other specifications (e.g., bur size compatibility, operating pressure, RPM), the ground truth is defined by engineering specifications and standards (I.S.O. and A.D.A. shank diameter standards).

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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K972375

SEP I 0 1997

510 (K) SUMMARY

I. Submitter :
Palisades Dental A Division of Glenwood, L.L.C. 82 N. Summit Street Tenafly, NJ 07670 Contact Person: Cynthia Romanoff Telephone: (800) 664-8000
Date 510(k) Summary Prepared: June 20, 1997 II.
Impact Air 45 Handpiece for Endodontic Use III. Trade Name:
IV. Classification Name: Dental Handpiece (21 C.F.R. §872.4200)
Predicate Devices: "Fiber Optic High Speed Handpiece" (K760794) V. and "Tradition High Speed Handpiece" (K863677), both manufactured by Midwest; the "Dental Handpiece" (K780038) by Lares Manufacturing Co.; and the "W-H Topair Dental Handpiece" (K912786) by Sabra.
Device Description: The Impact Air 45 Handpiece for Endodontic VI. Use is an air-powered dental handpiece intended for use in apicoectomy (root canal drainage) and other endodontic procedures for which a conventional handpiece would be used. The handpiece is intended to provide a better work environment than a conventional high-speed, air-powered handpiece in that (1) it is designed so that air is not directed onto the area of the bur and (2) it is designed with a 45-degree back-angled head shank to facilitate access.

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in the head of the device, thus spinning the bur. The air exits the device principally through an air exhaust tube in the handle. A smaller portion of the air exits through the top of the head of the device. Virtually no air exits from the front of the head into the area of the bur.

The Impact Air 45 can be sterilized by autoclave when processed for 35 minutes at 250 deqrees. Data indicate that after 250 sterilization cycles the handpiece continues to function appropriately.

VII. Substantial Equivalence: The Impact Air 45 is substantially equivalent to a number of conventional high-speed, air-powered dental handpieces including the "Fiber Optic High Speed Handpiece" (K760794) and "Tradition High Speed Handpiece" (K863677), both manufactured by Midwest; the "Dental Handpiece" (K780038) by Lares Manufacturing Co.; and the "W-H Topair Dental Handpiece" (K912786) by Sabra. Based on our familiarity with these devices, we have concluded that the Impact Air 45 has the same intended use, does not raise different questions of safety and effectiveness, and is fundamentally similar in operating principle, design, materials, energy source, and other characteristics.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles, suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure, emphasizing the department's name and national affiliation. The logo is simple, using only black and white, which gives it a clean and professional appearance.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 1997

Mr. John I. Gruen Member Glenwood, L.L.C. Glenwood-Palisades One New Enqland Avenue Piscataway, New Jersey 08855

K972375 Re: Impact Air 45 Handpiece for Endodontic Use Trade Name: Requlatory Class: I Product Code: EFB Dated: June 20, 1997 Received: June 25, 1997

Dear Mr. Gruen:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Paqe 2 - Mr. Gruen

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labelinq requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

N. Alatrist

Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use

Device Name:

Impact Air 45 Handpiece for Endodontic Use

Indications:

Susan Runner

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital I 510(k) Number .

Prescription Use
(Per 21 CFR 801.109)

(Per 21 CFR 801.109)

Regulation Number and Section

§ 872.4200 Dental handpiece and accessories.

(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.