TCM ENDO III

K013185 · NOUVAG AG · EFA · Nov 28, 2001 · Dental

Device Facts

• Record ID: K013185
• Device Name: TCM ENDO III
• Applicant: NOUVAG AG
• Product Code: EFA · Dental
• Decision Date: Nov 28, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The intended use of the TCM Endo III is to drive dental handpieces during root canal preparation.

Device Story

TCM Endo III is an AC-powered endodontic unit comprising a controller console, foot pedal, and motor. Device drives dental handpieces for root canal preparation. Motor provides maximum 1:1 drive output of 16,000 RPM. Entire motor assembly is autoclavable. Operated by dental professionals in a clinical setting to facilitate mechanical root canal instrumentation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

AC-powered endodontic unit; controller console, foot pedal, and motor; maximum 1:1 drive output of 16,000 RPM; 115V or 230V power supply; autoclavable motor assembly.

Indications for Use

Indicated for use by dental professionals to drive dental handpieces during root canal preparation procedures.

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.

Predicate Devices

• Analytic Endodontics, Quantec-E Endo System

Submission Summary (Full Text)

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NOV 2 82001

# SYBRON DENTAL SP

Section III - 510(k) Summary of Safety and Effectiveness

# Submitter:

Nouvag, A.G. St. Gallerstrasse, 23-25 CH-9403 Goldach Switzerland

Contact:

Colleen Boswell Sybron Dental Specialties, Inc. [phone] - Phone [phone] - Facsimile

Date Summary Prepared:

September 2001

## Device Name:

- Trade Name TCM Endo III .
K વ 3185

- Common Name AC-Powered Dental handpiece .
- Classification Name Dental Handpiece and Accessories, per 21 CFR § 872.4200 .

## Devices for Which Substantial Equivalence is Claimed:

- Analytic Endodontics, Quantec-E Endo System .
## Device Description:

The TCM Endo III is an AC-powdered endodontic unit consisting of a controller console, foot pedal and motor intended to drive dental handpieces during root canal preparation. The motor has a maximum 1:1 drive output of 16,000 Rpm's. The unit is supplied with either a 115V or 230V power cord. The entire motor assembly of the TCM Endo III is autoclavable.

## Intended Use of the Device:

The intended use of the TCM Endo III is to drive dental handpieces during root canal preparation.

## Substantial Equivalence:

TCM Endo III is substantially equivalent to other legally marketed devices in the United States. TCM Endo III functions in a manner similar to and is intended for the same use as the Quantec-E Endo System designed by Analytic Endodontics.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 8 2001

Nouvag AG C/O Ms. Colleen Boswell Consultant Sybron Dental Specialties, Incorporated . 1717 West Collins Avenue Orange, California 92867

Re: K013185

Trade/Device Name: TCM Endo III Regulation Number: 872.4200 Regulation Name: AC-Powered Dental Handpiece Regulatory Class: I Product Code: EFA Dated: September 21, 2001 Received: September 24, 2001

Dear Ms. Boswell:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have roviewed your betermined the device is substantially equivalent (for the releveloco above and nove atternslosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to act 1000 Cosmetic Act (Act) that do not require approval of a premarket the rodelar F ood, Drag, and Country, therefore, market the device, subject to the general approvin application (1 the Act. The general controls provisions of the Act include controls providents of an 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 If your device is classified (see as 10)ional controls. Existing major regulations affecting (1 Writ), it may of back of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or rounder further announcements concerning your device in the Federal Register.

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

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### Page 2 - Ms. Boswell

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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

Sincerely yours,

Timothy A. Ulatowski

Tim Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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Section I

Indications for Use Statement

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