SYNEA - LS LOW-SPEED HANDPIECE

K993526 · A-Dec, Inc. · EFB · Jan 11, 2000 · Dental

Device Facts

• Record ID: K993526
• Device Name: SYNEA - LS LOW-SPEED HANDPIECE
• Applicant: A-Dec, Inc.
• Product Code: EFB · Dental
• Decision Date: Jan 11, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

A dental low-speed handpiece is designed for removing carious material, cavity and crown preparation, excess filling material, root canal preparations, finishing tooth preparations, restorations and polishing teeth.

Device Story

Synea-LS is a dental low-speed handpiece used by dental professionals in clinical settings. Device connects to standard dental unit air/water supply; utilizes pneumatic power to drive rotary burs or polishing attachments. Operator controls speed and torque via dental unit foot pedal. Device facilitates mechanical removal of tooth structure, caries, and restorative materials; aids in finishing and polishing procedures. Benefits include precise material removal and surface refinement during restorative dentistry.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Pneumatic-powered dental handpiece; rotary mechanism for attachment of dental burs and polishing tools. Standard dental handpiece form factor.

Indications for Use

Indicated for dental procedures including removal of carious material, cavity and crown preparation, removal of excess filling material, root canal preparation, finishing of tooth preparations, and polishing of teeth in a dental clinical 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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/10 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three curved lines representing its wings. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 1 2000

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

Re : K993526 Trade Name: Synea - LS Low-Speed Handpiece Requlatory Class: I Product Code: EFB October 11, 1999 Dated: Received: October 18, 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 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 (Premarket Approval), 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 895. ਉ 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 regulation 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

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Page 2 - Mr. Ridenour

obligation you might have under sections 531 through 542 of 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 leqally 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 labelinq regulation (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 low-speed handpiece is designed for removing carious material, cavity and crown preparation, excess filling material, root canal preparations, finishing tooth preparations, restorations and polishing teeth.
Susan Runner

(Division Sign-Off) (Division Sign-Off)
Division of Dental, Infection Control, Divisioneral Hospital Devices 1000 25260 510(k) Number .

**Prescription Use**
**(Per 21 CFR 801.109)**