SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS

K073478 · Sybron Dental Specialties, Inc. · EFB · Sep 3, 2008 · Dental

Device Facts

• Record ID: K073478
• Device Name: SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: EFB · Dental
• Decision Date: Sep 3, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The SUPERtorque High-Speed Handpieces are intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry. The GENTLEpower Handpieces and Attachments are intended for the removal of carious material, excess filling material, reducing hard tooth structure, cavity and crown preparation, root canal preparation, finishing tooth preparations, restorations and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.

Device Story

SUPERtorque and GENTLEpower are reusable, air-powered or electric-motor-driven dental handpieces; used by trained dental professionals in clinical settings for tooth preparation, restoration, and polishing; devices feature ergonomic designs and optional fiber optic lighting; sterilized via steam autoclave; output is mechanical rotation for dental burs/instruments; aids clinicians in precise removal of tooth structure and restorative materials; benefits patients through efficient, controlled dental procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Air-powered or electric-motor-driven dental handpieces; reusable; ergonomic form factor; optional fiber optic light system; steam autoclave sterilization.

Indications for Use

Indicated for trained dental professionals to perform removal of carious/filling material, tooth structure reduction, cavity/crown/root canal preparation, finishing, and polishing in general dentistry patients.

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

• Siemens AG (now Sirona), T1 Control High Speed Dental Handpieces (K965238)
• DEN-TAL-EZ, Inc., STAR DENTAL 430 Series High Speed Handpieces (K960719)
• A-dec/W&H, Synea Air-Driven Highspeed Handpieces and Attachments (K070663)

Submission Summary (Full Text)

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K073478

Image /page/0/Picture/1 description: The image shows the logo for Sybron Dental Specialties, which includes the letters 'sds' in a stylized font with a swooping line above them. Below the logo, the text 'SYBRON DENTAL SPECIALTIES' is printed in a smaller, sans-serif font. The text 'Section III - 510(k) Summary of Safety and Effectiveness' is located below the company name.

SEP - 3 2008

Submitter:

Sybron Dental Specialties, Inc. 1717 West Collins Drive Orange, CA 92656 Colleen Boswell - Contact Person Date Summary Prepared: November 2007

#### Device Name:

- Trade Namc SUPERtorque High-Speed Handpieces �
- Common Name Dental Handpiece .
- Classification Name Handpiece, Air-Powered, Dental, per 21 CFR § 872.4200 .

## Devices for Which Substantial Equivalence is Claimed:

- Siemens AG (now Sirona), T1 Control High Speed Dental Handpieces (K965238) .
- DEN-TAL-EZ, Inc., STAR DENTAL 430 Series High Speed Handpieces (K960719). .

## Device Description:

The SUPERtorque High-Speed Handpieces are dental handpieces for use by a trained professional in general dentistry. The devices are air-powered handpieces that are reusable and ergonomically shaped, and are provided both with and without a fiber optic light system. The devices can be sterilized by the steam autoclave method.

## Intended Use of the Device:

The SUPERtorque High-Speed Handpieces are intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.

## Substantial Equivalence:

The SUPERtorque High-Speed Handpieces is substantially equivalent to other legally marketed devices in the United States. The intended use of the devices is identical to that of the predicate. The SUPERtorque High-Speed Handpieces are substantially equivvalent in design, application and function to the TI Control High Speed Dental Handpiees marketed by Siemens AG (now owned by Sirona) and STAR DENTAL 430 Series High Speed Handpieces marketed by DEN-TAI -EZ, Inc.

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# K073478

Image /page/1/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a simple, sans-serif font. The logo is black and white.

Section III - 510(k) Summary of Safety and Effectiveness

## Submitter:

Sybron Dental Specialties, Inc. 1717 West Collins Drive Orange, CA 92656 Colleen Boswell - Contact Person Date Summary Prepared: November 2007

#### Device Namc:

- . Trade Name - GENTLEpower Handpieces and Attachments
- . Common Name - Dental Handpiece and Accessories
- Classification Name Handpiece, Air-Powered, Dental, per 21 CFR § 872.4200 .

## Devices for Which Substantial Equivalence is Claimed:

- A-dec/W&H, Synea Air-Driven Highspeed Handpieces and Attachments (K070663) .
#### Device Description:

The GENTLEpower Handpieces and Attachments are dental instruments for use by a trained professional in general dentistry. The handpieces and attachments are powered by either an air-motor or electric motor. The devices are re-usable and ergonomically shaped, and can be sterilized by the steam autoclave method.

#### Intended Use of the Device:

The GENTLEpower Handpieces and Attachments are intended for the removal of carious material, excess filling material, reducing hard tooth structure, cavity and crown preparation, root canal preparation, finishing tooth preparations, restorations and for polishing tooth.

#### Substantial Equivalence:

The GENTLEpower Handpieces and Attachments are substantially equivalent to other legally marketed devices in the United States. The intended use of the devices is identical to that of the predicate. The GENTLEpower Handpieces and Attachments are substantially equivalent in design, application and function to the Synea Air-Driven Highspeed Handpieces and Attachments marketed by A-Dec/W&H.

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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 consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP - 3 2008

Ms. Colleen Boswell Vice President, Regulatory Affairs Sybron Dental Specialtics, Incorporated 1717 West Collins Avenue Orange, California 92867

Re: K073478

Trade/Device Namc: SUPERtorque High-Speed Handpieces and GENTI.Epower Handpieces and Attachments Regulation Number: 872.4200 Regulation Name: Dental Handpiecc and Accessories Regulatory Class: II Product Code: EFB Dated: August 29, 2008 Received: September 2, 2008

Dear Ms. Boswell:

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. Boswell

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 labcling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

MKAnnelle Kendon for //

Chiu S. Lin, Ph. D Division 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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# Indications for Use

#### 510(k) Number (if known):

Device Name: SUPERtorque High-Speed Handpieces

#### Indications for Use:

The SUPERtorque High-Speed Handpieces are intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

3

Conettreance of CDRH, Office of Device Evaluation (ODE)

Surenkane
(Division Sign-Off)

Division of Anesthes:ology, General Hospital Infection Control, Dental Devices

510(k) Number: KC73078

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# Indications for Use

#### 510(k) Number (if known):

Device Name: GENTLEpower Handpieces and Attachments

#### Indications for Use:

The GENTLEpower Handpieces and Attachments are intended for the removal of carious material, excess filling material, reducing hard tooth structure, cavity and crown preparation, root canal preparation, finishing tooth preparations, restorations and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concusrence of CDRH, Office of Device Evaluation (ODE)

Susan Fung

Division Sign-Off) ivision of Anesthesiology, General Hospital nrection Control, Dental Devices

10(k) Number:

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