DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM

K060287 · W&H Dentalwerk Buermoos GmbH · EBW · May 3, 2006 · Dental

Device Facts

• Record ID: K060287
• Device Name: DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM
• Applicant: W&H Dentalwerk Buermoos GmbH
• Product Code: EBW · Dental
• Decision Date: May 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Mechanical drive unit with coolant supply for transmission instruments with coupling system according to ISO 3964. The equipment is a drive unit for use in dental surgery, implantology and maxillo-facial surgery for treatment of dental hard tissue.

Device Story

Device is a surgical motor unit for dental applications. Components include a handheld motor, foot control, and controller. An integrated pump supplies coolant/fluid from a reservoir to the motor/handpiece to ensure irrigation during surgery. Operated by dental professionals in clinical settings. The unit drives transmission instruments with ISO 3964 coupling systems. It functions as a mechanical drive system to facilitate dental hard tissue procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Mechanical drive unit with integrated irrigation pump. Compatible with ISO 3964 transmission instruments. Includes controller, handheld motor, and foot control. No software-based algorithmic processing described.

Indications for Use

Indicated for use in dental surgery, implantology, and maxillo-facial surgery for the treatment of dental hard tissue.

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

• implantMED SI-95 (K002469)
• implantmed SI 915/923 (K052741)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for W&H Dentalwerk. The logo consists of the letters "W&H" inside of a hexagon on the left, and the word "DENTALWERK" on the right. The text is in bold, sans-serif font.

3 2006 MAY 510(k) Section 5

abel Versions of "implantMED Si-915/923"

## 510(k) SUMMARY

| Submitted by: | W & H Dentalwerk Buermoos GmbH<br>Ignaz-Glaser-Strasse 53<br>A - 5111 Buermoos<br>Austria |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Gabriele Wienbeck<br>Tel.: [phone]<br>Fax: [phone] |
| Date of Preparation: | 01/20/2006 |
| Device name: | Private Label Versions of "implantMED SI-915/923"<br>Such as "DrillTech", "Ism", " Implant Unit" and "Zimmer<br>Surgical Motor Unit" |
| Common Name: | Surgical motor unit for implantology and maxillo<br>surgery |
| Classification Name: | Controller, foot, handpiece and cord |
| Predicate devices: | implantMED SI-95 (K002469)<br>implantmed SI 915/923 ( K052741) |

### Device Description:

The device consists of a small hand held motor, a foot control and a controller. Accessories complete the device. They are designed for use in dental surrery. Optimum irrigation of the treatment site is an important factor for successful treatment. An integrated pump is used to supply the treatment fluid / oooolant from its reservoir via a pump to the motor / handpiece.

### Intended use:

Mechanical drive unit with coolant supply for transmission instruments with coupling system according to ISO 3964.

The equipment is a drive unit for use in dental surgery, implantology and maxillo-facial surgery for treatment of dental hard tissue.

## Technological Characteristics:

The technological characteristics of the private label versions are very similar to the previous implantMED versions. Differences result from the modification of the Intended Use and become manifest in programs and factory settings. Furthermore we offer an alternative foot control.

### Substantial equivalence:

The private label versions and the predicate device "implantMED SI-95" share the same indication for use.

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The comparison of the subject and the predicate device "implantMED SI-915/923" shows very similar technological characteristics. Performance properties and biocompatibility are the same.

The private label versions are substantially equivalent to those devices it was modified from.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with three parallel lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 2006

Ms. Gabriele Wienbeck Regulatory Affairs W&H Dentalwerk Büermoos GmbH Ignaz Glaser Strasse 53 Büermoos, Austria A-5111

Re: K060287

Trade/Device Name: Private Label Versions of implantMED SI-915/923 including accessories such as "Drilltech" "Ism" "ImplantUnit" "Zimmer Surgical Motor Unit" Regulation Number: 872.4200

Regulation Name: Dental Handpiece and Accessories Regulatory Class: I

Product Code: EBW Dated: February 2, 2006

Received: February 7, 2006

Dear Ms. Wienbeck:

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.

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Page 2 - Ms. Wienbeck

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 your 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clue
Chiu Lin, Ph.D.

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

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| W&H | DENTALWERK |
|-----|------------|
|-----|------------|

# INDICATION FOR USE

510(k) (if known):____________________________________________________________________________________________________________________________________________________________ Device Name: Private Label Versions of implantMED SI-915/923 incl. accessories such as "Drilltech" "Ism" "ImplantUnit" "Zimmer Surgical Motor Unit" Indication for Use: Mechanical drive unit with coolant supply for transmission instruments with coupling system according to ISO 3964. The equipment is a drive unit for use in dental surgery, implantology and maxillo-facial surgery for treatment of dental hard tissue.

Prescription Use (Part 21 CFR 801 Subpart D)

X

AND/OR

Over- The -Counter Use (21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Roe Muler for MCR

Technology, General Hospital,
Control, Luminal Devices