IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES

K052741 · W&H Dentalwerk Buermoos GmbH · EBW · Jan 13, 2006 · Dental

Device Facts

• Record ID: K052741
• Device Name: IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES
• Applicant: W&H Dentalwerk Buermoos GmbH
• Product Code: EBW · Dental
• Decision Date: Jan 13, 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, maxillo-facial surgery and endodontics for treatment of dental hard tissue and mechanical rotating root canal preparation

Device Story

ImplantMED SI-915/923 is a surgical motor unit for dental procedures. System comprises handheld motor, foot control, and controller unit. Integrated pump provides coolant/treatment fluid from reservoir to motor/handpiece to ensure optimal irrigation during surgery. Device serves as mechanical drive for transmission instruments with ISO 3964 coupling. Used by dental professionals in clinical settings for hard tissue treatment and root canal preparation. Output is mechanical rotation of dental instruments; healthcare provider controls speed and irrigation via foot pedal to perform surgical tasks. Benefits include controlled, cooled mechanical action for precise dental and maxillofacial procedures.

Clinical Evidence

No clinical data. Substantial equivalence based on technological characteristics and performance properties compared to the predicate device.

Technological Characteristics

Mechanical drive unit with integrated irrigation pump. Compatible with ISO 3964 coupling system. Available in 115V (SI-915) and 230V (SI-923) versions. Includes handheld motor, foot control, and controller. No software-based algorithmic processing described.

Indications for Use

Indicated for use in dental surgery, implantology, maxillofacial surgery, and endodontics for treatment of dental hard tissue and mechanical rotating root canal preparation.

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 (K002469)

Reference Devices

• implantMED SI-95

Submission Summary (Full Text)

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K052741

Image /page/0/Picture/2 description: The image shows the logo for W&H DENTALWERK. The logo consists of two parts: a hexagon containing the letters "W&H" and the word "DENTALWERK" written in bold, sans-serif font. The hexagon is located to the left of the word "DENTALWERK". The logo is simple and professional, and it is likely used to represent a dental company or organization.

510(k) implantMED SI-915/923

Section 5 Page 1 of 1

## 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: | 15/08/2005 |
| Device name: | implantMED SI-915/923 |
| Common Name: | Surgical motor unit for implantology and maxill<br>surgery |
| Classification Name: | Controller, foot, handpiece and cord |
| Predicate device: | implantMED (K002469) |

### Device Description:

The implantMED SI-915/923 consist of a small hand held motor, a foot control and a controller. Accessories complete the device. They are designed for use in dental surgery.

Optimum irrigation of the treatment site is an important factor for successful treatment. An integrated pump is used to supply the treatment fluid / coolant 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, maxillofacial surgery and endodontics for treatment of dental hard tissue and mechanical rotating root canal preparation.

Technological Characteristics:

The "implantMED SI-915/923" is the update of the previous version. The technological characteristics are very similar to the old device.

### Substantial equivalence:

The updated and the predicate device share the same indication for use. Comparisons of the subject and the previous version show similar technological characteristics, performance properties and biocompatibility. The "implantMED SI-915/923" is substantially equivalent to the device it was modified from, the "implantMED SI-95"

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN I 3 2006

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

Re: K052741

Trade/Device Name: ImplantMED SI-915 (115V Version) ImplantMED SI-923 (230V Version) Incl. Accessories Regulation Number: 872.4200 Regulation Name: dental Handpiece and Accessories Regulatory Class: I Product Code: EBW Dated: December 16, 2005 Received: December 16, 2005

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,

Suyle y. Michael Davis

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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Image /page/3/Picture/0 description: The image shows a logo with the letters "W&H" inside of a hexagon. To the right of the logo, the word "DENT" is written in bold, sans-serif font. The logo and the word are both in black and white.

# INDICATION FOR USE

510(k) (if known):_____________K052741

Device Name: implantMED SI-915 (115V version) implantMED SI-923 (230V version) incl. accessories

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, maxillo-facial surgery and endodontics for treatment of dental hard tissue and mechanical rotating root canal preparation

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russe

ന്റേറ്റ് അവനം on Corrist, Dental Devices