CONTRA-ANGLE HANDPIECE KOMET OS30 by W & H DENTALWERK BUERMOOS GMBH

The dental contra-angle handpiece "KOMET - OS30" is intended for mechanical interproximal enamel reduction (stripping, slenderizing) in use of an oscillating movement

Device Description

The dental handpiece attachment "KOMET - OS30" is a drive, in order to enable the mechanical interproximal enamel reduction by means of the oscillating movement of the attached "KOMET - OS Discs". "OS30" is provided with a coupling system according to ISO 3964, allowing the handpiece's attachment onto a corresponding dental motor. The handpiece's gearing elements transmit the motor's rotational movement up to the integrated head gear, where this movement is converted into an oscillating one. The "OS Disc", chucked in the said head gear, oscillates in an angle of 30°, depending on the motor's speed with max. 5.000 oscillations/min.

AI/ML Overview

The provided document is a 510(k) Pre-market Notification for a dental contra-angle handpiece. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a formal study with detailed performance metrics.

Therefore, the document does not contain the requested information regarding acceptance criteria, a specific study proving device performance, sample sizes, expert involvement, adjudication methods, or MRMC/standalone studies as typically found for AI/imaging device submissions.

Here's why and what information can be extracted:

Acceptance Criteria & Reported Device Performance: This document states "Bench testing results demonstrate substantially equivalence," but does not provide a table of specific acceptance criteria or quantitative performance data. The device is a mechanical contra-angle handpiece, not an AI or diagnostic imaging device that would typically have performance metrics like sensitivity, specificity, or AUC against a ground truth. Its acceptance is based on demonstrating it functions similarly to existing, cleared devices.
Sample Size (Test Set) and Data Provenance: Not applicable. Performance testing for this device would likely involve mechanical and functional benchmarks, not a "test set" of patient data.
Number of Experts and Qualifications: Not applicable. Ground truth for this type of mechanical device is typically established through engineering specifications and functional testing, not expert clinical interpretation.
Adjudication Method: Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is a mechanical device, not an AI diagnostic tool where human reader performance would be a factor.
Standalone (Algorithm Only) Performance: Not applicable. This is a mechanical device, not an algorithm.
Type of Ground Truth: For a dental handpiece, the "ground truth" would be engineering specifications and successful functional operation (e.g., maintaining oscillations, durability, safety parameters). The document implies that this was established through "bench testing results."
Sample Size for Training Set: Not applicable. This is a manufactured product, not a machine learning model.
How Ground Truth for Training Set Was Established: Not applicable.

Summary of available information related to performance/equivalence:

Acceptance Criteria/Reported Device Performance:
- Acceptance Criteria (Implied): Substantial equivalence to predicate devices (Dentsply International: "Interproximal Reduction System", K053368, and A-dec Incorporated: "A-dec/W&H Synea Profin Reciprocating Contra-Angle Handpiece Attachment WA-67...", K082827). This implies meeting similar safety and performance envelopes as the predicates.
- Reported Device Performance: "Bench testing results demonstrate substantially equivalence." The device is described to convert rotational movement into an oscillating movement, with the "OS Disc" oscillating in an angle of 30°, depending on the motor's speed, with max. 5,000 oscillations/min. This performance is consistent with its intended mechanical function and similar to predicate devices.
Sample Size (Test Set) and Data Provenance: Not provided/Not applicable given the device type.
Number of Experts and Qualifications: Not provided/Not applicable.
Adjudication Method: Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No.
Standalone Performance Study: No, as it's a mechanical device. Performance was assessed via "bench testing results."
Type of Ground Truth: The ground truth for proving substantial equivalence was based on engineering specifications and functional performance verified through "bench testing."
Sample Size for Training Set: Not applicable.
How Ground Truth for Training Set Was Established: Not applicable.

Summary

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	510(k) Contra-Angle Handpiece"KOMET - OS30"
510(k) SUMMARY		JUN 30 200
Applicant and Owner	W&H Dentalwerk Buermoos GmbHIgnaz-Glaser-Strasse 53A - 5111 Buermoos - AustriaTel.: 0043 -6274 / 6236 -297Fax: 0043 -6274 / 6236 -234
Contact Person	Johann Georg SCHARL
Date of Preparation	February 24th, 2009
Device Name	Contra-Angle Handpiece "KOMET - OS30"
Classification Name	Handpiece, Air-Powered, Dental
Regulation Number	21 CFR872.4200
Product Code	EFB
Predicate Devices	Dentsply International:"Interproximal Reduction System", K053368
	A-dec Incorporated:
	"A-dec/W&H Synea Profin Reciprocating Contra-Angle
	Handpiece Attachment WA-67...", K082827
Device Description	The dental handpiece attachment "KOMET - OS30" is a drive, inorder to enable the mechanical interproximal enamel reductionby means of the oscillating movement of the attached "KOMET -OS Discs". "OS30" is provided with a coupling system accordingto ISO 3964, allowing the handpiece's attachment onto acorresponding dental motor. The handpiece's gearing elementstransmit the motor's rotational movement up to the integratedhead gear, where this movement is converted into an oscillatingone. The "OS Disc", chucked in the said head gear, oscillates inan angle of 30°, depending on the motor's speed with max.5.000 oscillations/min.
Intended Use:	The dental contra-angle handpiece "KOMET - OS30" is intendedfor mechanical interproximal enamel reduction (stripping,slenderizing) in use of an oscillating movement.
TechnologicalCharacteristics	The handpiece "KOMET - OS30" represents a further variant ofW&H's dental contra-angle handpieces series Synea, whichalready have been cleared by A-dec Inc. under the 510(k)numbers K993526, K070663 and just recently K053368.While the main technical characteristics have been retainedunchanged, the new product's transmission elements prompt thechucked tool to move in an oscillating manner.
Comparison of thedevice to the predicatedevice	The intended use, technological characteristics and performanceparameter are very similar to the predicate device cleared byDentsply International. The technological characteristics and thematerials furthermore are very similar to ones of the productscleared by A-dec Inc.The new device is substantially equivalent to the predicatedevices.
Performance Testing	Bench testing results demonstrate substantially equivalence
Clinical Testing	Clinical data were not needed for this new product.

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Rev.00

Feb. 4th, 2009

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three legs and three wing segments. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

JUN 3 0 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Johann Georg Scharl Regulatory Affairs Manager W& H Dentalwerk Buermoos GmbH Ignaz-Glaser-Strasse 53 Buermoss Salzburg A-5111 AUSTRIA

Re: K090548

Trade/Device Name: Contra-Angle Handpiece "KOMET-OS30" Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: June 23, 2009 Received: June 25, 2009

Dear Mr. Scharl:

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 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.

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Page 2- Mr. Scharl

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours

Susan Cunne

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| W&H | 510(k) Contra-Angle Handpiece
"KOMET - OS30" | Section 4

Page 1 of 1
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K090548

Indications for Use

Device Name:

Contra-Angle Handpiece "KOMET - OS30"

Indication for Use:

The dental contra-angle handpiece "KOMET - OS30" is
intended for mechanical interproximal enamel reduction
(stripping, slenderizing) in use of an oscillating movement

Labels	Values
Prescription Use	X
(Part 21 CFR 801 Subpart D)
AND/OR
Over The Counter Use
(Part 21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Muly for MSR

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number: K090548

Feb. 4th, 2009

100

Rev. 00

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.