A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT

K032572 · A-Dec, Inc. · EBW · Dec 3, 2003 · Dental

Device Facts

• Record ID: K032572
• Device Name: A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT
• Applicant: A-Dec, Inc.
• Product Code: EBW · Dental
• Decision Date: Dec 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The A-dec/W&H Electric Motor kit is a device system comprised of a control unit that drives a DC micromotor that is activated by means of a footswitch. It is intended for general dental applications such as: cutting a tooth for cavity preparation, finishing, inlay, filing, polishing, prophylaxis and endodontic treatment, with use of a straight, right-angle, or contra-angle ISO E-type handpiece attachment of equal speed, gear-reduction speed, or gear-increasing speed.

Device Story

System consists of control unit, DC micromotor, and footswitch. Used in dental clinics by dentists/dental professionals. Footswitch activation drives micromotor; motor connects to ISO E-type handpieces (straight, right-angle, contra-angle) for various dental tasks (cutting, polishing, endodontics). Output is mechanical rotation of handpiece bur/tool. Benefits include precise control for restorative and endodontic procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

DC micromotor system; ISO E-type handpiece interface; footswitch-controlled; electrical energy source; Class I device.

Indications for Use

Indicated for general dental procedures including cavity preparation, finishing, inlay, filing, polishing, prophylaxis, and endodontic treatment. Suitable for use with ISO E-type handpiece attachments.

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

DEC - 3 2003

Mr. Tom Louisell A-dec. Incorporation 2601 Crestview Drive Newberg, Oregon 97132

Re: K032572

18052972
Trade/Device Name: A-Dec/ W&H Electric Motor Motor, Model EA-50LT Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EBW Dated: November 14, 2003 Received: November 19, 2003

Dear Mr. Louisell:

We have reviewed your Section 510(k) premarket notification of intent to market the device we mayor of the would your 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 Intersule comments prices that have been reclassified in accordance with the provisions of Amendinents, or to actrices that motic 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 ennifols provisions of a 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 (1 Mr.), it may be subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be nother 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 r lease be act 100 a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. or the rece of ally I outs 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 requirements as betronic 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/dsma/dsmamain.html

Sincercly yours,

Patticia Cucurulloe

Chiu Lin, Ph.D. Director Division of Anesthesiology, Gcneral Hospital, Infection Control and Dental Devices Office of Device Livaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: A-dec/W&H Electric Motor

Indications For Use:

The A-dec/W&H Electric Motor kit is a device system comprised of a control unit The A doorward Lloothe micromotor that is activated by means of a footswitch. It that drived a D C Chowneral dental applications such as: cutting a tooth for cavity lo anondou for alle in gown finishing, inlay, filing, polishing, polishing, prophylaxis and endodontic treatment, with use of a straight, right-angle, or contra-angle ISO E-type handpiece attachment of equal speed, gear-reduction speed, or gearincreasing speed.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OROver-The-Counter Use (Optional Format 1-2-96)

Susan Richard

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

510(k) Number: K032570