FRC POSTEC

K013802 · Ivoclar Vivadent, Inc. · ELR · May 1, 2002 · Dental

Device Facts

• Record ID: K013802
• Device Name: FRC POSTEC
• Applicant: Ivoclar Vivadent, Inc.
• Product Code: ELR · Dental
• Decision Date: May 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3810
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

FRC Postec is intended for use by dentists to give retention for reconstruction of endontically treated teeth

Device Story

FRC Postec is a root canal post used by dentists to provide retention for the reconstruction of endodontically treated teeth. The device is placed within the root canal to support restorative materials. It functions as a structural component to aid in tooth restoration.

Clinical Evidence

Bench testing only.

Technological Characteristics

Root canal post; Class I device; Product Code ELR; 21 CFR 872.3810.

Indications for Use

Indicated for use by dentists to provide retention for the reconstruction of endodontically treated teeth.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 0-1 2002

Ms. Donna M. Hartnett Assistant Corporate Counsel Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228

Re: K013802

Trade/Device Name: FRC POSTEC Regulation Number: 872.3810 Regulation Name: Post, Root Canal Regulatory Class: I Product Code: ELR Dated: February 20, 2002 Received: February 26, 2002

### Dear Ms. Hartnett:

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.

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.

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### Page 2 -- Ms. Donna M. Hartnett

You must comply with all the Act's requirements, including, but not limited to: registration r od intere (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and fisuling (21 et ready in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as betrenic 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 110(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 and cautionally July 594-4613. 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 alle Free may or stance 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 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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. #

| 510(k) Number (if known): | Pending K013802 |
|---------------------------|-----------------|
|---------------------------|-----------------|

| | | | and the contribution of the count |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Device Name: | FRC POSTEC<br>110 1 2 3 1 1 2 3 1 1 2 3 1 1 2 3 1 1 2 3 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| | | | |

Indications For Use:

FRC Postec is intended for use by dentists to give retention for reconstruction of endontically treated teeth

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

Susan Runne

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510/k) Number 170/ 280 J 510(k) Number 10

(Optional Format 1-2-96)