MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD)

K021250 · Handpiece Unlimited · EBF · Oct 24, 2002 · Dental

Device Facts

• Record ID: K021250
• Device Name: MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD)
• Applicant: Handpiece Unlimited
• Product Code: EBF · Dental
• Decision Date: Oct 24, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2

Intended Use

The device is an air-powered dental handpiece for use by a trained professional in general dentistry.

Device Story

MK-dent HS 2012/2014 are air-powered dental handpieces (Standard and Small head models) used by dental professionals in clinical settings. Device operates via air pressure (30-32 psi) to drive a turbine for dental procedures. Key design features include an auto-chuck mechanism with increased spring strength (8 lbs bur retention vs 6 lbs in predicate) to reduce risk of bur ejection. Physical design improvements include reduced weight (2 oz) to minimize operator fatigue and softened handle knurling to facilitate cleaning/sterilization and improve tactile grip. Device is intended for general dentistry; output is mechanical rotation for dental work. Benefits include improved bur retention, ergonomic handling, and easier sterilization compliance.

Clinical Evidence

Bench testing only. Validation confirmed the ability to repeatedly sterilize the devices via steam autoclave. Biocompatibility is ensured through the use of materials with the same specifications as the predicate device.

Technological Characteristics

Air-powered dental handpiece. Materials: copper-tin bronze housing, nickel silver turbine housing, stainless steel turbine cap. Energy source: 30-32 psi air pressure. Form factor: 2 oz weight, knurled handle. Sterilization: steam autoclave. Conforms to ISO standards.

Indications for Use

Indicated for use by trained professionals in general dentistry for air-powered dental procedures.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Predicate Devices

• KaVo 625 Dental Handpiece (K760929)

Submission Summary (Full Text)

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### 4. Summary of Safety and Effectiveness

OCT 2 4 2002 4.1 ldentification of Device

MK-dent® Push Button Highspeed Handpiece, 4 Holes, Trade Name: Models: HS 2012 (Standard Head) and HS 2014 (Small Head)

Handpiece, air-powered, dental Common/Usual Name:

Classification Name: Dental handpiece

Device Class: Class I

76 EFB Product Code

# 4.2 Equivalent Device

Equivalent leqally marketed device: KaVo 625 Dental Handpiece (K760929)

### 4.3 Indications for Use

The device is an air-powered dental handpiece for use by a trained professional in general dentistry.

### Description of Device 4.4

The MK-dent® HS 2012/2014 shares virtually all specifications and design characteristics of the predicate devices. This was done intentionally by the designers and engineers. The only major design change refers to the strength of the auto chuck mechanism. By increasing the spring strength, we have created a more reliable version compared to KaVo 625. By increasing the bur retention strength from 6 lbs (as with the predicate device) to 8 lbs. (MK-dent® HS 2012/2014) we have been able to vastly reduce the odds of a bur prematurely ejecting from the handpiece. A few minor changes to the predicate device which do not affect the performance but we feel make the handpiece convenient to use are as follows: Reduction in the weight of the handpiece to 2 oz.. This reduces operator hand fatigue. Softening the knurling on the handle. This allows dirt, blood and salvia to be more easily removed from the body shell of the handpiece, thus allowing better conformity to sterilization procedures. It also provides better tactile sense to the operator while wearing gloves.

### 4.5 Safety and Effectiveness, comparison to predicate device

| Element of Comparison | - KaVo 625 Handpieces (K760929) | MK-dent® HS 2012/2014 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Intended Use | General dentistry by trained professional | SAME |
| Materials: | - Handpiece housing: - Copper-tin bronze<br>- Turbine housing: - Nickel silver CDA alloy<br>- Turbine housing cap: - Stainless steel | SAME |

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| - Plating | - Chrome | |
|---------------|-------------------------|-----------------|
| Energy Source | Air pressure, 30-32 psi | SAME |
| Sterilization | Steam autoclave or ETO | Steam autoclave |

# 4.6 Conclusion

In all respects, the MK-dent® HS 2012/2014 is substantially equivalent to one or more air-powered 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 devices has been confirmed by validation protocol.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

Dr. Martina Günderoth C.R.C. Partnerschaftsgesellschaft Katharinenstr. 5 23554 Lübeck, GERMANY

Re: K021250

Trade/Device Name: MK-dent® HS 2012/2014 Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EBF Dated: August 8, 2002 Received: August 19, 2002

Dear Dr. Günderoth:

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.

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.

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Page 2 - Dr. Günderoth

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Ulatowski 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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510(k) Notification: MK-Dent® HS 2012 Dental Handpiece

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# Indications for Use 3.

510(k) Number ________________________________________________________________________________________________________________________________________________________________

Device Name: MK-dent® HS 2012/2014

Indications for Use: The device is an air-powered dental handpiece for use by a trained professional in general dentistry.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_

OR

Over the Counter Use (Per 21 CFR 801.109)

Espitz DDS for Dr. Susan Kummer

(Division Sign-Off) (Division Sign-On)"
Division of Anesthesiology, General Hospital, Division of Ansolnoomsental Devices

510(k) Number: K021250