A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT

K082827 · A-Dec, Inc. · EFB · Jan 7, 2009 · Dental

Device Facts

• Record ID: K082827
• Device Name: A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT
• Applicant: A-Dec, Inc.
• Product Code: EFB · Dental
• Decision Date: Jan 7, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The A-dec/W&H Synea Profin reciprocating contra-angle handpiece attachment is intended for use in removing protrusions or excess of filling materials and cements, preparation, finishing and polishing in the interdental and subgingival regions, stripping, vibrating of inlays using Dentatus tips and root canal preparations using endodontic files.

Device Story

Reciprocating contra-angle handpiece attachment; connects to dental handpiece motor. Transforms rotary motion into reciprocating motion for specialized dental tips/files. Used by dentists in clinical settings for interdental/subgingival procedures: removing excess filling/cement, finishing, polishing, stripping, inlay vibration, and root canal preparation. Enhances precision in confined spaces; improves efficiency of restorative and endodontic workflows.

Clinical Evidence

Bench testing only.

Technological Characteristics

Reciprocating contra-angle handpiece attachment. Mechanical gear-driven mechanism converts rotary input to reciprocating output. Compatible with standard dental handpiece motors. Models include LT (light) and A variants. Non-sterile; intended for sterilization by the user.

Indications for Use

Indicated for dental professionals performing interdental/subgingival removal of filling/cement protrusions, preparation, finishing, polishing, stripping, inlay vibration, and root canal preparation.

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

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 7 2009

Mr. Thomas H. Louisell Regulatory Compliance Manager A-dec, Incorporated 2601 Crestview Drive Newberg, Oregon 97132-9257

Re: K082827

Trade/Device Name: A-dec/W&H Synea Profin Reciprocating Contra-Angle Handpiece Attachment WA-67/1.1 LT, WA-67/0.4 LT, WA-67/1.1 A, WA-67/0.4 A

Regulation Number: 21 CFR 872.4200

Regulation Name: Dental Handpiece and Accessories

Regulatory Class: I

Product Code: EFB

Dated: December 29, 2008

Received: January 5, 2009

Dear Mr. Louisell:

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 - Mr. Louisell

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 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 vours.

Susan Turner
Ginette Y. Michaud, M.D.

Ginette Y. Michaud, M. D. Division Acting 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

#### 1 of 1 Page

K082827

510(k) Number (if known):_

Device Name:

A-dec/W&H Synea Profin reciprocating contra-angle handpiece attachment WA-67/1.1 LT, WA-67/0.4 LT, WA-67/1.1A, WA-67/0.4A

Indications For Use:

The A-dec/W&H Synea Profin reciprocating contra-angle handpiece attachment is intended for use in removing protrusions or excess of filling materials and cements, preparation, finishing and polishing in the interdental and subgingival regions, stripping, vibrating of inlays using Dentatus tips and root canal preparations using endodontic files.

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Prescription Use ﮯ (Per 21 CFR 801Subpart D) OR

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

Susan Cuarres

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: