TCM ENDO 20

K081191 · NOUVAG AG · EKX · Aug 7, 2008 · Dental

Device Facts

• Record ID: K081191
• Device Name: TCM ENDO 20
• Applicant: NOUVAG AG
• Product Code: EKX · Dental
• Decision Date: Aug 7, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The TCM Endo 20 is a dental root treatment device for enlarge the root canal with a rotating, high elastic file.

Device Story

TCM Endo 20 is a transportable, cord-connected dental endodontic device. It consists of a microprocessor-controlled electronic motor system with a standard E-type handpiece adapter. The device controls rotational speed and torque for root canal enlargement. Users set parameters including speed, torque limit, contra-angle ratio, rotation direction, and program selection (1-9). It features two torque-limiting modes: Automatic Limiter (AL) and Automatic Reverse (AR). The device is operated by dental professionals in a clinical setting. By maintaining constant speed until a torque threshold is reached, the device protects the endodontic file from breakage, potentially improving procedural safety and efficiency during root canal treatment.

Clinical Evidence

Bench testing only. The device was designed and tested to applicable safety standards; no clinical data was required or provided.

Technological Characteristics

Microprocessor-controlled electronic motor system; E-type handpiece adapter; plastic enclosure; cord-connected; user-adjustable speed, torque, and rotation direction; sterilization of motor and cable up to 134°C.

Indications for Use

Indicated for dental root canal enlargement using a rotating, high elastic file. Prescription use only.

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

• NOUVAG AG TCM Endo V (K042822)

Submission Summary (Full Text)

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K081191

NOUVAG AG TCM Endo 20

510(k) Notification April 16, 2008 :

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### SECTION 5

AUG - 7 2008

### 510(k) Summary

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

Contact Person: Markus Gemperle Quality Manager / RA Phone [phone] [phone] Fax

Date Summary Prepared: April 16, 2008

Device Name:

Proprietary Name TCM Endo 20

Common Name Endodontic Device

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:

NOUVAG AG TCM Endo V K042822, Cleared on 12/22/2004

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## Device Description:

The TCM Endo 20 is a transportable, cord connected equipment, provided with a plastic enclosure which has two connection ports for the footswitch and the electronic motor. It is a microprocessor controlled electronic motor system which controls the rotational speed and the torque of the motor. The rotational speed is constant until the torque reaches the adjusted level.

In order to protect the rimmer, you can choose between two torque controlling modes -the Automatic Limiter (AL) and the Automatic Reverse (AR) mode.

The electronic motor has a standard E-type handpiece adapter that accepts any E-type contra angle and handpiece (E-fitting).

The following parameters can be set by the user:

- "Speed" increase or decrease rotational speed
- "Torque" select torque maximum
- -"Motor" -- Switch on/off electronic motor
- "Ratio" Select ratio of the contra angle -
- -"Symbol reverse" - Select rotating direction: R (Right) clockwise: L (Left, reverse) counterclockwise
- -"Prog" - Select Program 1 to 9
- -"AL/AR" - Choose between AL- and AR- mode

#### Sterility:

Motor and motor cable: Sterility by user up to 134°C.

#### Intended use of the Devices:

The TCM Endo 20 is a dental root treatment device for enlarge the root canal with a rotating, high elastic file.

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

The TCM Endo 20 is substantially equivalent to other legally marketed devices in the United States. The TCM Endo 20 functions in a manner similar and is intended for the same use as the TCM Endo V (Predicate device)

## Brief summary of nonclinical tests and results:

The TCM Endo 20 has been designed and tested to applicable safety standards. The TCM Endo 20 does not raise any new issues of safety, effectiveness, or performance of the product.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG - 7 2008

NOUVAG AG C/O Ms. Erich Forster Quality Manager / Regulatory Affairs INTRATest GmbH Reusswehrstrasse 1 Gebenstorf CH-5412 SWITZERLAND

Re: K081191

Trade/Device Names: TCM Endo 20 Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: July 8, 2008 Reccived: July 14, 2008

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: registertion 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation cntitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely vours.

Sincerely yours,

TH Normuly ferdi r-2

pxu

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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# K081191

510(k) Number (if known):

Device Name: TCM Endo 20

Indications for Use:

The TCM Endo 20 is a dental root treatment device for enlarge the root canal with a rotating, high elastic file.

## (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 X
(per 21 CFR 801.109)

OR

Over-The-Counter Use_

Susan Ryner

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

1971-191 510(k) Number: