The Interproximal Reduction System handpiece includes an air-driven low-speed motor and a contra-angle integrated with the head. It is used with the abrasive strips for interproximal reduction/stripping, polishing, or preparation of tooth for placement of orthodontic appliances (aligners, brackets, retainers, etc.)

AI/ML Overview

This 510(k) summary describes an Interproximal Reduction System, which is a dental handpiece and accessories. The filing states that "All of the components found in the Interproximal Reduction System have been used in legally marketed devices and were found safe for dental use. We believe that the prior use of the components in legally marketed predicate devices and test results support the safety and effectiveness of the Interproximal Reduction System for the indicated uses."

Based on the provided text, a detailed study proving the device meets specific acceptance criteria is not included. The submission relies on the substantial equivalence to predicate devices, asserting that the components have been previously deemed safe and effective in other legally marketed devices.

Therefore, for your request, I will indicate that the information is not provided as it pertains to specific acceptance criteria and a study demonstrating their achievement for this particular device.

Here's a breakdown of the requested information:

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

Acceptance Criteria: Not provided in the document.
Reported Device Performance: Not provided in the document. The filing relies on the established safety and effectiveness of individual components in predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not provided.
Data Provenance: Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not applicable, as no specific test set requiring expert ground truth is described.
Qualifications of Experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable, as no specific test set is described.

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

MRMC Comparative Effectiveness Study: Not performed or described. This device is a dental handpiece, not an AI-assisted diagnostic tool.

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

Standalone Performance Study: Not performed or described. This device is a mechanical handpiece, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: Not applicable, as no specific test requiring ground truth is described. The basis for safety and effectiveness is substantial equivalence to predicate devices.

8. The sample size for the training set

Sample Size: Not applicable, as this is a mechanical device, not an AI system that requires a training set.

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

Ground Truth Establishment: Not applicable as there is no training set for this device.

Summary

{0}------------------------------------------------

K053368

510(k) SUMMARY

MAR 2 9 2006

DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872

CONTACT: Helen Lewis

DATE PREPARED: December 2, 2005

TRADE OR PROPRIETARY NAME: Interproximal Reduction System

CLASSIFICATION NAME: Dental Handpiece and Accessories (21 CFR, Part 872.4200)

PREDICATE DEVICES: Synea-LS Low Speed Handpiece (K993526) W&H Air Motor A25 (K944711)

DEVICE DESCRIPTION:

INTENDED USE:

The Interproximal Reduction System is intended for use as a method of achieving interproximal reduction of teeth.

TECHNOLOGICAL CHARACTERISTICS:

All of the components found in the Interproximal Reduction System have been used in legally marketed devices and were found safe for dental use. We believe that the prior use of the components in legally marketed predicate devices and test results support the safety and effectiveness of the Interproximal Reduction System for the indicated uses.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures, one behind the other, with their arms raised.

MAR 2 9 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DENTSPLY International Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17404

Re: K053368

Trade/Device Name: Interproximal Reduction System Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB, EGS Dated: March 13, 2006 Received: March 13, 2006

Dear Ms. Lewis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{2}------------------------------------------------

Page 2 -Ms. Lewis

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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

Enclosure

{3}------------------------------------------------

INDICATIONS FOR USE

510(K) Number (if known): K053368

Interproximal Reduction System Device Name:

Indications for Use:

The Interproximal Reduction System is indicated as a method for achieving interproximal reduction of teeth.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suser Rummy
(Division Sign-Off)

Division of Anasthooloov, General Hospital, Infoclion Control, Demizi

510(k) Number: K053368

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.