EXCEL HIGH SPEED DENTAL HANDPIECE

K061581 · Orthosource, Inc. · EFA · Aug 16, 2006 · Dental

Device Facts

• Record ID: K061581
• Device Name: EXCEL HIGH SPEED DENTAL HANDPIECE
• Applicant: Orthosource, Inc.
• Product Code: EFA · Dental
• Decision Date: Aug 16, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The dental high speed handpiece is a precision instrument used by a dental professional for the removal of carious tissue, the preparation of teeth for restorations, for crowns and bridges, and for cosmetic corrections. Note Federal Law restricts the use of this device to dental professionals.

Device Story

Excel High Speed Hand Piece is a precision dental instrument; used by dental professionals in clinical settings. Device functions as a high-speed rotary tool for removal of carious tissue and tooth preparation for restorative procedures (crowns, bridges, cosmetic corrections). Operates via pneumatic or electric power to drive a bur; facilitates mechanical cutting of tooth structure. Output is the physical removal of dental material. Benefits include efficient tooth preparation and restoration. No software or automated algorithms involved.

Clinical Evidence

No clinical data provided; device is a standard dental handpiece subject to general controls.

Technological Characteristics

High-speed dental handpiece; mechanical rotary instrument; intended for use with standard dental burs. No software, electronic components, or complex algorithms. Sterilization via standard autoclave methods for dental instruments.

Indications for Use

Indicated for dental professionals to remove carious tissue and prepare teeth for restorations, crowns, bridges, and cosmetic corrections.

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)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 16 2006

Lloyd Taylor, DDS Owner/Operator OrthoSource, Incorporated 13343 Sherman Way North Hollywood, California 91605

Re: K061581

Trade/Device Name: Excel High Speed Hand Piece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFA Dated: June 5, 2006 Received: June 7, 2006

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 Amendinents, 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 approvisions 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 – 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 (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,

Sylite Y. Micham O.M.D.

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

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## Indications for Use

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

Device Name: Excel High Speed Hand Piece Indications For Use:

> The dental high speed handpiece is a precision instrument used by a dental professional for the removal of carious tissue, the preparation of teeth for restorations, for crowns and bridges, and for cosmetic corrections. Note Federal Law restricts the use of this device to dental professionals.

Prescription Use × (Part 21 CFR 801 Subpart D)

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

061581

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Renner

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