A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43

K082716 · A-Dec, Inc. · EFB · Jan 15, 2009 · Dental

Device Facts

• Record ID: K082716
• Device Name: A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43
• Applicant: A-Dec, Inc.
• Product Code: EFB · Dental
• Decision Date: Jan 15, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The A-dec/W&H Alegra Air-Driven Highspeed Handpiece is an air-powered dental handpiece. This device is designed for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth. The A-dec/W&H Alegra Handpiece Attachment is powered by either an air-motor or electric motor for general dentistry. This device is designed for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth.

Device Story

Air-driven high-speed handpieces and motor-powered attachments for general dentistry; used by dental professionals in clinical settings. Devices remove carious material, prepare cavities/crowns, perform root canal preparations, finish restorations, and polish teeth. Operates via air-motor or electric motor power. Handpieces and attachments facilitate mechanical dental procedures; output is the physical removal or finishing of tooth structure/restorative material. Benefits include efficient dental tissue management and restorative preparation.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Air-driven and motor-powered dental handpieces and attachments. Includes LED-integrated models. Mechanical dental instrumentation. No software or electronic algorithms.

Indications for Use

Indicated for general dentistry procedures including removal of carious material, excess filling material, cavity and crown preparation, root canal preparation, finishing tooth preparations, 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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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with three talons, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 1 5 2009

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

Re: K082716

Trade/Device Name: A-dec/W&H Alegra Air-Driven Highspeed Handpiece, Models TE-98, TE-97 A-dec/W&H Alegra Handpiece Attachment, Models WE-99 LED G, WE-66 LED G, WE-57 LED G, WE-56 LED G, HE-43A

Regulation Number: 21 CFR 872.4200

Regulation Name: Dental Handpiece and Accessories

Regulatory Class: II

Product Code: EFB

Dated: January 6, 2009

Received: January 7, 2009

ﺗﮭ

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 yours,

Sman Punner

Ginette Y. Michaud, M.D. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

Page 1 of 1

510(k) Number (if known):

Device Name:

A-dec/W&H Alegra Air-Driven Highspeed Handpiece, models TE-98, TE-97 A doo/W&H Alegra Handpiece Attachment, models WE-99 LED G, WE-66 LED G, WE-57 LED G, WE-56 LED G, HE-43 A

Indications For Use:

The A-dec/W&H Alegra Air-Driven Highspeed Handpiece is an air-powered dental The A dool North Ribgia Mira Listing This device is designed for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth.

The A-dec/W&H Alegra Handpiece Attachment is powered by either an air-motor or The A door War PAlogra Hariageneral dentistry. This device is designed for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth.

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Prescription Use 4 (Per 21 CFR 801Subpart D)

| OR | Susan Runne |
|---------------------|------------------------|
| | Over-The-Counter Use |
| | (21 CFR 801 Subpart C) |
| (Division Sign-Off) | |

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

10