EXCEL CONTRA ANGLE HANDPIECE

K061897 · Orthosource, Inc. · EGS · Feb 14, 2007 · Dental

Device Facts

• Record ID: K061897
• Device Name: EXCEL CONTRA ANGLE HANDPIECE
• Applicant: Orthosource, Inc.
• Product Code: EGS · Dental
• Decision Date: Feb 14, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The dental slow speed handpiece is a precision instrument used by a dental professional at slow speed (100 to 20,000 rpm) for the removal of carious tissue, the preparation of teeth for restorations, for crowns and bridges, for cosmetic correction, and for the trimming, finishing, and polishing of all types of dental restorations and prostheses. Note: Federal Law restricts the use of this device to dental professionals.

Device Story

Excel Contra Angle Hand Piece is a dental slow-speed handpiece; operates at 100 to 20,000 rpm. Used by dental professionals in clinical settings for removal of carious tissue, tooth preparation, and finishing/polishing of restorations and prostheses. Device functions as a mechanical instrument; provides precision control for dental procedures. Benefits include efficient tissue removal and restoration finishing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Slow-speed dental handpiece; operating range 100-20,000 rpm. Mechanical instrument for dental procedures. No software or electronic components.

Indications for Use

Indicated for dental professionals to perform removal of carious tissue, tooth preparation for restorations, crowns, and bridges, cosmetic correction, and trimming, finishing, and polishing of dental restorations and prostheses.

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.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/11 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Lloyd R. Taylor President OrthoSource, Incorporated 13343 Sherman Way North Hollywood, California 91605

FEB 1 4 2007

Re: K061897

Trade/Device Name: Excel Contra Angle Hand Piece Regulation Number: 872,4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EGS Dated: January 11, 2007 Received: January 17, 2007

Dear Dr. Taylor:

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.

{1}------------------------------------------------

## Page 2 -Dr. Taylor

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 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.

Snytte y. Michael Dms.

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

{2}------------------------------------------------

K061897

## Indications for Use

## 510(k) Number (if known): To Be Assigned

## Device Name: Excel Contra Angle Hand Piece Indications For Use:

The dental slow speed handpiece is a precision instrument used by a dental professional at slow speed (100 to 20,000 rpm) for the removal of carious tissue, the preparation of teeth for restorations, for crowns and bridges, for cosmetic correction, and for the trimming, finishing, and polishing of all types of dental restorations and prostheses. Note: Federal Law restricts the use of this device to dental professionals.

× Prescription Use (Part 21 CFR 801 Subpart D)

AND /OR Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runver

(Division Sign-Off) (Division Sign-Olf)
Division of Anasthesiology, General Hospital, Infection Control, Cental Devices

510(k) Number: k061897