SYNEA-HS HIGH SPEED-HANDPIECE

K992011 · A-Dec, Inc. · EFB · Sep 10, 1999 · Dental

Device Facts

• Record ID: K992011
• Device Name: SYNEA-HS HIGH SPEED-HANDPIECE
• Applicant: A-Dec, Inc.
• Product Code: EFB · Dental
• Decision Date: Sep 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

A dental high-speed handpiece is designed for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.

Device Story

Synea-HS is a high-speed dental handpiece used by dentists in clinical settings. Device functions as a rotary instrument to remove carious material, reduce tooth structure, prepare cavities, finish restorations, and polish teeth. Operates via pneumatic power to drive a bur or other rotary tool. Clinician controls speed and application directly to the tooth surface. Benefits include efficient tooth structure removal and restoration finishing during routine dental procedures.

Clinical Evidence

No clinical data provided; device is a mechanical dental handpiece.

Technological Characteristics

High-speed dental handpiece; pneumatic power source; rotary instrument interface; Class I device.

Indications for Use

Indicated for dental patients requiring removal of carious material, reduction of hard tooth structure, cavity preparation, finishing of preparations and restorations, and tooth polishing.

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

SEP 1 0 1999

Mr. Patrick Ridenour Engineering Services Manager A-Dec, Incorporated 2601 Crestview Drive 97132-9257 Newberg, Oregon

Re : K992011 Synea-HS High-Speed Handpiece Trade Name: Requlatory Class: I Product Code: EFB Dated: June 11, 1999 Received: June 15, 1999

Dear Mr. Ridenour:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 -Mr. Ridenour

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 marice and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE: .

A dental high-speed handpiece is designed for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.

PRESCRIPTION Use

(Division Sign-Off)
Division of Dental, Infection Control
and General Hospital Devices
510(k) Number.

K992011