CONTRA-ANGLE HANDPIECE KOMET OS30

K090548 · W&H Dentalwerk Buermoos GmbH · EFB · Jun 30, 2009 · Dental

Device Facts

• Record ID: K090548
• Device Name: CONTRA-ANGLE HANDPIECE KOMET OS30
• Applicant: W&H Dentalwerk Buermoos GmbH
• Product Code: EFB · Dental
• Decision Date: Jun 30, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

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

Device Story

The KOMET-OS30 is a dental contra-angle handpiece attachment designed for mechanical interproximal enamel reduction. It connects to a standard dental motor via an ISO 3964 coupling. The device transforms the motor's rotational input into an oscillating output through internal gearing. An attached 'KOMET-OS Disc' oscillates at a 30° angle, with a maximum speed of 5,000 oscillations per minute. Used by dentists in clinical settings, the device facilitates enamel stripping/slenderizing procedures. The oscillating motion allows for controlled material removal, aiding in orthodontic or restorative treatment planning.

Clinical Evidence

Bench testing only. No clinical data were required for this device.

Technological Characteristics

Contra-angle handpiece with ISO 3964 coupling. Mechanical transmission converts rotational motor input to 30° oscillating output. Max speed 5,000 oscillations/min. Materials and design are based on the W&H Synea series. Sterilizable device.

Indications for Use

Indicated for dental patients requiring mechanical interproximal enamel reduction (stripping or slenderizing) performed by a dental professional.

Regulatory Classification

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.

Predicate Devices

• Interproximal Reduction System (K053368)
• A-dec/W&H Synea Profin Reciprocating Contra-Angle Handpiece Attachment WA-67 (K082827)

Reference Devices

• Synea dental contra-angle handpieces (K993526)
• Synea dental contra-angle handpieces (K070663)
• Synea dental contra-angle handpieces (K053368)

Submission Summary (Full Text)

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| | 510(k) Contra-Angle Handpiece<br>"KOMET - OS30" | Section 5<br>Page 1 of 1 | | |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|------------|--|
| 510(k) SUMMARY | | | JUN 30 200 | |
| Applicant and Owner | W&H Dentalwerk Buermoos GmbH<br>Ignaz-Glaser-Strasse 53<br>A - 5111 Buermoos - Austria<br>Tel.: [phone]<br>Fax: [phone] | | | |
| 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:<br>"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, in<br>order to enable the mechanical interproximal enamel reduction<br>by means of the oscillating movement of the attached "KOMET -<br>OS Discs". "OS30" is provided with a coupling system according<br>to ISO 3964, allowing the handpiece's attachment onto a<br>corresponding dental motor. The handpiece's gearing elements<br>transmit the motor's rotational movement up to the integrated<br>head gear, where this movement is converted into an oscillating<br>one. The "OS Disc", chucked in the said head gear, oscillates in<br>an angle of 30°, depending on the motor's speed with max.<br>5.000 oscillations/min. | | | |
| Intended Use: | The dental contra-angle handpiece "KOMET - OS30" is intended<br>for mechanical interproximal enamel reduction (stripping,<br>slenderizing) in use of an oscillating movement. | | | |
| Technological<br>Characteristics | The handpiece "KOMET - OS30" represents a further variant of<br>W&H's dental contra-angle handpieces series Synea, which<br>already have been cleared by A-dec Inc. under the 510(k)<br>numbers K993526, K070663 and just recently K053368.<br>While the main technical characteristics have been retained<br>unchanged, the new product's transmission elements prompt the<br>chucked tool to move in an oscillating manner. | | | |
| Comparison of the<br>device to the predicate<br>device | The intended use, technological characteristics and performance<br>parameter are very similar to the predicate device cleared by<br>Dentsply International. The technological characteristics and the<br>materials furthermore are very similar to ones of the products<br>cleared by A-dec Inc.<br>The new device is substantially equivalent to the predicate<br>devices. | | | |
| Performance Testing | Bench testing results demonstrate substantially equivalence | | | |
| Clinical Testing | Clinical data were not needed for this new product. | | | |

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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 [phone] or [phone] 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 |
|-------------|
|-------------|

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

| <strong>Labels</strong> | <strong>Values</strong> |
|-----------------------------|-------------------------|
| 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

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