DENTAL HANDPIECE

K971732 · Pauline M. Nicholls · EFB · Jan 11, 2000 · Dental

Device Facts

• Record ID: K971732
• Device Name: DENTAL HANDPIECE
• Applicant: Pauline M. Nicholls
• Product Code: EFB · Dental
• Decision Date: Jan 11, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

AS ALL OTHER DENTAL HANDPIECES, WILL THIS DENTAL HANDPIECE, BE USED INTRA AND EXTRA ORALLY TO CENTAL DEVICES CRIND AND POLISH TEETH, OR ITEMS RELATED TO TEETH AND DENTAL DEVICES THAT MAY BE IN THE MOUTH OR TO BE PLACED IN THE MOUTH.

Device Story

Dental handpiece designed for intra-oral alignment with the long axis of teeth; facilitates grinding and polishing of teeth and dental appliances. Operated by dental professionals in clinical settings. Device provides improved alignment ergonomics compared to existing high-speed handpieces, enhancing safety during dental procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material similarity to existing legally marketed dental handpieces.

Technological Characteristics

Constructed of brass, chrome, and/or stainless steel. Mechanical dental handpiece. No electronic or software components described.

Indications for Use

Indicated for intra- and extra-oral grinding and polishing of teeth, dental devices, or items related to teeth and dental devices intended for placement in the mouth.

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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**JAN 1 1 2000**

## 510(k) SUMMARY OR STATEMENT

THE DEVICE CONCERNED IS 510(k) NUMBER K971732, DENTAL HANDPIECE.

THE DENTAL HANDPIECE, PATENT NUMBER 5575647, WAS DESIGNED TO INTRA-ORALLY, ALIGNED WITH THE LONG AXIS OF EACH TOOTH. THIS EASE OF ALIGNMENT IN ALL AREAS OF THE MOUTH DECIDEDLY GIVES THE HANDPIECE A SAFETY MARGIN OVER ANY EXISTING HIGHSPEED HANDPIECE, UPON WHICH THE SUBSTANTIAL EQUIVALENCE IS BASED.

ALL DENTAL HANDPIECES, SINCE THEIR INCEPTION IN THE LATE 1800'S, HAVE BEEN CONSRUCTED OF THE SAME MATERIALS: BRASS AND CHROME,OR STAINLESS, OR A COMBINATION OF BOTH. AALL DENTAL HANDPIECES HAVE BEEN BOTH DURABLE AND SAFE.

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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 1 1 2000

Dr. Kenneth Grubbs, D.D.S. 101 Davis Street Monroe, Georgia 30655

K971732 Re : Dental Handpiece Trade Name: Requlatory Class: I Product Code: EFB Dated: October 21, 1999 Received: October 25, 1999

Dear Dr. Grubbs:

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 regulations 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) requlation (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

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Page 2 - Dr. Grubbs

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 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 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.fdaygov/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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## 510(K) #971732

## STATEMENT OF INDICATIONS FOR USE

THIS IS A STATEMENT OF INDICATIONS FOR USE, CONCERNING 510(K) NUMBER K971732, DENTAL HANDPIECE.

AS ALL OTHER DENTAL HANDPIECES, WILL THIS DENTAL HANDPIECE, BE USED INTRA AND EXTRA ORALLY TO CENTAL DEVICES CRIND AND POLISH
TEETH, OR ITEMS RELATED TO TEETH AND DENTAL DEVICES THAT MAY BE IN THE MOUTH OR TO BE PLACED IN THE MOUTH.

Susan Runyon

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

> Prescription Use _ (Per 21 CFR 801.109)