TENAX WHITE POST

K993545 · Coltene/Whaledent, Inc. · ELR · Apr 14, 2000 · Dental

Device Facts

• Record ID: K993545
• Device Name: TENAX WHITE POST
• Applicant: Coltene/Whaledent, Inc.
• Product Code: ELR · Dental
• Decision Date: Apr 14, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3810
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Tenax White Posts are for use where ever endodontic posts are required and where esthetic considerations and/or where known allergies to metals are of concern..

Device Story

Tenax White Post is an endodontic post system used in dental restorative procedures. It serves as a structural support for tooth restoration in patients requiring endodontic treatment, particularly when metal-free or esthetic solutions are preferred. The device is used by dentists in a clinical setting. It provides a foundation for core build-up materials, aiding in the restoration of endodontically treated teeth. By offering a non-metallic alternative, it benefits patients with metal sensitivities and improves the final esthetic outcome of the dental restoration.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Endodontic post system designed for esthetic applications and metal-free requirements. Specific material composition and ASTM standards are not detailed in the provided text.

Indications for Use

Indicated for patients requiring endodontic posts, specifically those with esthetic requirements or known metal allergies.

Regulatory Classification

Identification

A root canal post is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be cemented into the root canal of a tooth to stabilize and support a restoration.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, featuring three wavy lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 4 2000

H.J. Vogelstein Mr. Official Correspondent Coltène/Whaledent Inc. 750 Corporate Drive Mahwah, New Jersey 07430-2009

K993545 Re : Tenax White Post Trade Name: Requlatory Class: I Product Code: ELR Dated: January 14, 2000 Received: January 18, 2000

Dear Mr. Vogelstein:

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 aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 obligation you might have under sections 531 through 542 of

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Page 2 — Mr. Vogelstein

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

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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## Coltène/Whaledent Inc.

## 510(k) Submission Tenax White Post

Indications for Use

Tenax White Posts are for use where ever endodontic posts are required and where

esthetic considerations and/or where known allergies to metals are of concern..

Susan Runos

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