EXTENDED STRAIGHT ATTACHMENT

K994024 · Team Technologies, Inc. · EGS · Feb 3, 2000 · Dental

Device Facts

• Record ID: K994024
• Device Name: EXTENDED STRAIGHT ATTACHMENT
• Applicant: Team Technologies, Inc.
• Product Code: EGS · Dental
• Decision Date: Feb 3, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

The Extended Length Disposable Prophy Angle is to be used during a prophylaxis treatment to polish the tooth surfaces of a patient.

Device Story

The Extended Length Disposable Prophy Angle is a dental instrument used by dental professionals during prophylaxis treatments. It attaches to a standard dental handpiece to facilitate the polishing of tooth surfaces. As a disposable device, it is intended for single-patient use to assist in the removal of plaque and stains, thereby supporting oral hygiene maintenance.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable dental prophy angle; extended length design; mechanical attachment to dental handpiece; intended for single-use.

Indications for Use

Indicated for use during dental prophylaxis treatment to polish tooth surfaces in patients requiring dental cleaning.

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

3 2000 FEB

Mr. Bob Walton Team Technologies, Incorporated 5949 Commerce Boulevard Morristown, Tennessee 37814

Re: K994024 Extended Straight Attachment Disposable Trade Name: Prophy Anqle Requlatory Class: I Product Code: EGS Dated: November 23, 1999 Received: November 26, 1999

Dear Mr. Walton:

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 reqistration, 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. ਸਿ substantially equivalent determination assumes compliance with the Good Manufacturinq 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 requlation may result in requlatory 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. Walton

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.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timot 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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## Statement of Indications for Use

The Extended Length Disposable Prophy Angle is to be used during a prophylaxis treatment to polish the tooth surfaces of a patient.

Susan Rann

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices વિદ્યારા કુલ તિ 510(x) Number ________________________________________________________________________________________________________________________________________________________________