MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED HANDPIECE AND TM20 LOW SPEED HANDPIECE

K070001 · Mti Precision Products · EFB · Feb 2, 2007 · Dental

Device Facts

• Record ID: K070001
• Device Name: MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED HANDPIECE AND TM20 LOW SPEED HANDPIECE
• Applicant: Mti Precision Products
• Product Code: EFB · Dental
• Decision Date: Feb 2, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

The Lube Free Low Speed Handpiece line comprises a family of air driven low speed dental motors, FDA classification code EFB, for use in dental non-surgical operatory and laboratory procedures by licensed practitioners. The dental motors are known as: Master Classic 5KLow Speed Handpiece Master Classic 20K Low Speed Handpiece Master TM5 5K Low Speed Handpiece Master TM20 20K Low Speed Handpiece The following are examples for which the motors can be utilized. Note that these are just examples and not limitations of the procedures for which the handpieces can be used. - . Grinding and trimming on dentures and bridge work. - Polishing and finishing of natural dentition . - Endodontio abcess procedures . - Cavity preparation. t - Crown and cap preparation . - Post and pin setting . - Implant setting . The handpieces utilize materials known for their ability to withstand many exposures to common cleaning and disinfection and steam sterilization.

Device Story

Air-driven low-speed dental handpieces; used by licensed practitioners in dental operatory or laboratory settings. Device connects to air supply; coupled with various attachments/angle heads to provide specific torque and speed ranges for non-surgical procedures. Enables grinding, trimming, polishing, and preparation tasks. Benefits patient by facilitating restorative and endodontic dental care. Handpieces constructed from materials compatible with standard cleaning, disinfection, and steam sterilization.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Air-driven low-speed dental motor; pneumatic energy source. Materials selected for compatibility with cleaning, disinfection, and steam sterilization. Form factor includes various attachments and angle heads for torque/speed adjustment. Standalone device.

Indications for Use

Indicated for use by licensed practitioners in dental non-surgical operatory and laboratory procedures, including grinding/trimming dentures/bridges, polishing/finishing natural dentition, endodontic access, cavity/crown/cap preparation, and post/pin/implant setting.

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

• Lynx Classic 5K Classic Air Motor (K940261)
• Lynx TM5 - 5K (K940261)
• Lynx TM20 - 20K Torquemaster (K940261)

Submission Summary (Full Text)

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Ko7000/

Page 1 of 2

Joseph Deluta

# 510(K) Submission

| PREPARED BY: | |
|--------------|-------------|
| | Tod Brenner |
| DATE: | 12/23/06 |

| DATE: | 12-23-06 |
|-------|----------|
|-------|----------|

APPROVED BY:

# TITLE: LUBE FREE LOW SPEED HANDIPIECE PRODUCT LINE

# SECTION 5: 510(k) SUMMARY

FEB - 2 2007

The following submission has been prepared pursuant to requirements specified in 21CFR, Para 807.92

### Contact Information:

Tod Brenner, Vice President, Engineering and Manufacturing MTI Dental Products 175 Oberlin Ave., North Lakewood, NJ. 08701 Phone: [phone] Fax: [phone]

Date: October 25, 2006

### Trade Names:

A

Master Classic 5K Low Speed Handpiece Master Classic 20K Low Speed Handpiece Master TM5 Low Speed Handpiece - -Master TM20 Low Speed Handpiece

### Common Name:

Low Speed Air Driven Dental Handpiene

Classification Name:

Handpiece, Air-Powered (21 CFR 872.4200)

ునుండి విశ్రీ శాసన

· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·

#### Classification Product Code: ------------------------------------EFB

Predicate Devices:

| A month and the county of the county of the county of the first of the first of the first of the first of the first of the first of the first of the first of the first and<br>Lynx Classic 5K Classic Air Motor | K940261 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Lynx TM5 - 5K | K940261 |
| Lynx TM20 - 20K Torquemaster | K940261 |

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## Device Description:

The Master line of air driven handpieces are intended for use in a variety of non-surgical dental laboratory and operatory applications. They are typically coupled with a selection of attachments and angle heads to provide the licensed practitioner with the correct range of torque and speed to perform the desired procedure.

## Intended Uses:

The Master product line of air motors will be used in dental laboratory and operatory nonsurgical procedures by licensed practitioners.

The following are examples for which the motors can be utilized. Note that these are just examples and not limitations of the procedures for which the handpieces can be used.

- Grinding and trimming on dentures and bridge work. .
- Polishing and finishing of natural dentition .
- Endodontic access procedures .
- . Cavity preparation.
- Crown and cap preparation .
- . Post and pin setting
- Implant setting .

The handpieces utilize materials commonly krown for their ability to withstand many exposures to common cleaning and disinfecting agents and steam sterilization.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Tod H. Brenner Vice President MTI Precision Products 175 Oberlin Avenue North Lakewood, New Jersey 08701

Re: K070001

Trade/Device Name: Master Classic 5K Low Speed Handpiece Master Classic 20K Low Speed Handpiece Master TM5 5K Low Speed Handpiece Master TM20 20K Low Speed Handpiece ------------------------------------------------------------------------------------------------------------------------------------------------------Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: December 5, 2006 Received: January 3, 2007

FEB - 2 2007

Dear Mr. Brenner:

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 - Mr. Brenner

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. or the Fet of any vith 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,

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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MTI PRECISION PRODUCTS
175 Oberlin Avenue
Lakewood, New Jersey 08701

K070001

| | Page 1 of 1 |
|--|-------------|
|--|-------------|

510(K) Submission

| PREPARED BY: | Tod Brenner |
|--------------|-------------|
| DATE: | 12/23/06 |

| APPROVED BY: | Joseph Deluca |
|--------------|---------------|
| DATE: | 12-23-06 |

TITLE: LUBE FREE LOW SPEED HANDPIECE PRODUCT LINE# SECTION 4: STATEMENT OF INDICATIONS FOR USE

The Lube Free Low Speed Handpiece line comprises a family of air driven low speed dental motors, FDA classification code EFB, for use in dental non-surgical operatory and laboratory procedures by licensed practitioners. The dental motors are known as:

Master Classic 5KLow Speed Handpiece Master Classic 20K Low Speed Handpiece Master TM5 5K Low Speed Handpiece Master TM20 20K Low Speed Handpiece

The following are examples for which the motors can be utilized. Note that these are just examples and not limitations of the procedures for which the handpieces can be used.

- . Grinding and trimming on dentures and bridge work.
- Polishing and finishing of natural dentition .
- Endodontio abcess procedures .
- Cavity preparation. t
- Crown and cap preparation .
- Post and pin setting .
- Implant setting .

The handpieces utilize materials known for their ability to withstand many exposures to
common cleaning and disinfection and steam sterilization.

(Division Sign-Off)
Division of Anesthesiology, General Hospital

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K070001