MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K

K032234 · Mk-Dent GmbH · EFB · Oct 2, 2003 · Dental

Device Facts

• Record ID: K032234
• Device Name: MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K
• Applicant: Mk-Dent GmbH
• Product Code: EFB · Dental
• Decision Date: Oct 2, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

The device is an air-powered dental handpiece providing light through a glass optic rod for use by a trained professional in general dentistry.

Device Story

MK-dent® High Speed Dental Handpiece is an air-powered tool used by dental professionals in clinical settings for general dentistry. The device utilizes a glass optic rod to provide illumination during procedures. It functions as a standard air-driven turbine handpiece. The device is designed to be compatible with existing dental unit couplings and is intended for repeated sterilization. It provides the clinician with a handheld instrument for performing dental work, with the light source aiding visibility in the oral cavity. The device is constructed to meet ISO standards for performance and safety, ensuring it functions similarly to existing market-cleared dental handpieces.

Clinical Evidence

Bench testing only. The device's safety and effectiveness were established through adherence to ISO standards (ISO 7785-1, 1797, 3964, 27785) and validation of sterilization protocols.

Technological Characteristics

Air-powered dental handpiece with integrated glass optic rod for illumination. Materials match predicate specifications to ensure biocompatibility. Conforms to ISO 7785-1 (turbines), ISO 1797 (shank/spindle strength), ISO 3964 (coupling), and ISO 27785 (sound/coolant). Sterilization via validated protocols.

Indications for Use

Indicated for use by trained dental professionals in general dentistry procedures requiring an air-powered handpiece with integrated light.

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

• KaVo Dental Handpiece, Series 630 and 640 (K760929)
• MK-dent® High Speed Dental Handpiece (K021250)

Submission Summary (Full Text)

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| OCT - 2 2003 510(k) Summary of safety and effectiveness | | |
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| Applicant: | MK-dent GmbH<br>Eichenweg 7B<br>22941 Bargteheide, Germany | K032234 |
| Contact: | Dr. Martina Günderoth<br>C.R.C. Partnerschaftsgesellschaft<br>Katharinenstr. 5<br>23554 Lübeck, Germany<br>Phone: [phone] / Fax: [phone]<br>Email: [e-mail] | |
| Device Name: | MK-dent® High Speed Dental Handpiece, Models HS4021K,<br>HS4011K, HS4012K, HS6021K, HS6011K, and HS6012K | |
| Common Name: | Handpiece, air-powered, dental | |
| Classification Name: | Dental handpiece | |
| Device Class: | Class I | |
| Product Code: | 76 EFB | |
| Code of Federal Regulations: | 21 CFR 872.4200 | |
| Indications for Use: | The device is an air-powered dental handpiece providing light<br>through a glass optic rod for use by a trained professional in<br>general dentistry | |

Predicate Device Name: KaVo Dental Handpiece, Series 630 and 640 (K 760929) MK-dent® High Speed Dental Handpiece (K 021250)

# Description of Device:

The MK-dent® HS Handpiece shares virtually all specifications and design characteristics of the predicate devices. This was done intentionally by the designers and engineers. Only few minor changes implemented to the predicate device make the MKdent® Handpiece more convenient to use but do not affect the performance, safety or effectiveness of it.

### Substantially Equivalence - Safety and Effectiveness:

In all respects, the MK-dent® Handpiece is substantially equivalent to one or more airpowered dental handpieces currently marketed in the USA. The handpiece is constructed of materials of the same specifications as the predicate device to ensure biocompatibility. The handpiece conforms to applicable ISO standards. The ability to repeatedly adequately sterilize the device has been confirmed by validation protocol.

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## Voluntary standard compliance:

- ISO Standard 7785-1: High speed dental turbines
- ISO Standard 1797: Shank dimensions
- ISO Standard 3964: Coupling device
- ISO Standard 27785: Sound level
- ISO Standard 27785: Water coolant
- ISO Standard 1797: Spindle strength

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of three abstract shapes that resemble a stylized human figure or a bird in flight. The overall design is simple and recognizable, representing the department's mission and identity.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 2 2003

MK-Dent Gmbh C/O Dr. Martina Gunderoth C.R.C. Partherschaftsgesellschaft Katharinenstr. 5 23554 Lubeck, Germany

Re: K032234

Trade/Device Name: MK-Dent High Speed Dental Handpiece, Models HS4021k KS4011K, HS4012K, HS6021K, HS6011K, and HS6012K Regulation Number: 872.4200 Regulation Name: Dental handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: June 24, 2003 Received: July 21, 2003

Dear Dr. Gunderroth:

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 vour 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 - Dr. Gunderoth

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 [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/dsma/dsmamain.html

Sincerely yours,

Susan Runner

Susan Runner, DDS, MA Interim 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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#### 3. Indications for Use

510(k) Number K032234

Device Name: MK-dent® High Speed Handpiece, Models HS 4021 K, HS 4011 K, HS 4012 K, HS 6021 K, HS 6011 K, and HS 6012 K

Indications for Use: The device is an air-powered dental handpiece providing light through a glass optic rod for use by a trained professional in general dentistry.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Pein Muluy for MSR

510(k) Number. K 032234

Prescription Use OR (Per 21 CFR 801.109)

Over the Counter Use