TCM ENDO V, MODEL 1534

K042822 · NOUVAG AG · EKX · Dec 22, 2004 · Dental

Device Facts

• Record ID: K042822
• Device Name: TCM ENDO V, MODEL 1534
• Applicant: NOUVAG AG
• Product Code: EKX · Dental
• Decision Date: Dec 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The TCM Endo V is a dental root canal measurement and treatment device that can measure the length of the root canal and enlarge the root canal while monitoring the position of the file tip inside the canal.

Device Story

TCM Endo V is a transportable, cord-connected, microprocessor-controlled endodontic device with integrated apex locator. Input: electrical signals from file tip position via reference electrode (lip connector). Operation: device measures root canal length; user selects rotational speed (150-2000 rpm), apex adjustment, and torque limits (5-40Nmm). Automatic Torque Control (ATC) monitors torque; upon reaching limit, motor reverses one revolution then resumes forward rotation to prevent file breakage. Auto-control modes include Auto Slow/Down, Auto Reverse, and Auto Stop. Output: motor-driven endodontic file rotation and visual/auditory feedback on file tip position. Used in dental clinics by dentists/endodontists. Benefits: enables precise root canal preparation, prevents file breakage, and monitors canal depth during treatment.

Clinical Evidence

Bench testing only. The device was designed and tested to applicable safety standards to demonstrate performance equivalent to predicate devices.

Technological Characteristics

Microprocessor-controlled endodontic handpiece. Features: apex locator, micro-motor, foot-control, and reference electrode. User-adjustable parameters: rotational speed (150-2000 rpm), torque (5-40Nmm), and auto-control modes. Sterilization: autoclavable components up to 134°C. Connectivity: cord-connected. Power: AC-powered (100V/115V/230V).

Indications for Use

Indicated for dental patients requiring root canal measurement and enlargement procedures. Used by dental professionals for monitoring file tip position within the canal.

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

• J. Morita USA, Inc. DENTAPORT ZX (K031204)
• J. Morita USA, Inc. DENTA PORT (K022147)

Submission Summary (Full Text)

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NOUVAG AG TCM Endo V

K042822

510(k) Notification October 08, 2004

DEC 22 2004

## SECTION 10

## 510(k) Summary

Submitter:

NOUVAG AG St. Gallerstrasse 23-25 CH-9403 Goldach Switzerland

Contact Person: Benno Frei Technical Director, New Product Development Phone [phone] 0041 71 845 35 36 Fax

Date Summary Prepared: October 08, 2004

Device Name:

Proprietary Name TCM Endo V Common Name Endodontic Device with Apex locator Classification Name Handpiece, Direct Drive, Ac-powered (per 21 CFR section 872.4200)

Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:

J. Morita USA, Inc. DENTAPORT ZX K031204, Cleared on 08/21/2003

J. Morita USA, Inc. DENTA PORT K022147, Cleared on 12/20/2002

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## Device Description:

The TCM Endo V is a transportable, cord connected, microprocessor-controlled endodontic device with Apex Locator. It is provided with a plastic enclosure which has four electrical connection ports for the detachable power supply cord, the foot-control, the micro-motor and the reference electrode (lip connector).

The Apex Locator measures the distance between file tip and Apex. If a minimum distance is preselected, the selected auto-control mode is activated thus ensuring that the minimum distance is reached.

The speed is held constantly under all circumstances until the maximum adjusted torque limit is reached. The Automatic Torque Control (ATC) protection mode ensures that no file breakage occurs. Once the preselected torque limit has been reached, the motor will immediately reverse for one revolution, then returns to forward direction. This ensures a fast and effective root canal preparation.

The following parameters can be set by the user;

- mains voltage (100V/115V/230V) -
- rotational speed (150-2000 rpm)
- "Apex adjust" (-1 to 0) -
- automatic torque limitation "ATC" (5-40Nmm) -
- "Auto control" mode ("Auto Slow / Down", "Auto Reverse"; "Auto Stop") -
- micro-motor ON/OFF "Motor"

## Sterility:

Contra Angle, Motor and motor cable, and lip connector: Sterility by user up to 134°C.

## Intended use of the Devices:

The TCM Endo V is a dental root canal measurement and treatment device that can measure the length of the root canal and enlarge the root canal while monitoring the position of the file tip inside the canal.

# Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device:

The TCM Endo V is substantially equivalent to other legally marketed devices in the United States. The TCM Endo V functions in a manner similar and are intended for the same use as the Devices designed by J. Morita USA, Inc.

## Brief summary of nonclinical tests and results:

The TCM Endo V has been designed and tested to applicable safety standards. The TCM Endo V does not raise any new issues of safety, effectiveness, or performance of the product.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 22 2004

NOUVAG AG C/O Mr. Erich Forster Regulatory Consultant INTRATest Systems GmbH Reusswehrstrasse 1 CH-5412 Gebenstorf / Switzerland

Re: K042822

Trade/Device Name: TCM Endo V Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Access Series Regulatory Class: I Product Code: EKX Dated: October 8, 2004 Received: October 12, 2004

Dear Mr. Forster:

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. Forster

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 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

Sincerely yours,

Anthony D. Chiu Lin, Ph.D.

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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K042822

NOUVAG AG TCM Endo V

510(k) Notification October 08, 2004

510(k) Number (if known): K042822

Device Name: TCM Endo V

Indications for Use:

The TCM Endo V is a dental root canal measurement and treatment device that can measure the length of the root canal and enlarge the canal while monitoring the position of the file tip inside the canal.

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurence of CDRH, Office of Device Evaulation (ODE)

(Optional Format 3-10-98)

Prescription use
(per 21 CFR 801.109)

... ...

OR

Over-The-Counter Use

Ken Mcaley for HSE

(Division Sign-Off) (Civision Sign-Only)
Division of Anesthesiology, General Hospital, Division Control, Dental Devices

510(k) Number: K042822