CARBON POST

K012496 · J. Morita USA, Inc. · ELR · May 17, 2002 · Dental

Device Facts

• Record ID: K012496
• Device Name: CARBON POST
• Applicant: J. Morita USA, Inc.
• Product Code: ELR · Dental
• Decision Date: May 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3810
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Carbon Post is a root canal post for use with composite resin cement in a prepared root canal in a non-vital tooth to stabilize and support a restoration.

Device Story

Carbon Post is a dental root canal post; used to stabilize and support restorations in non-vital teeth. Device is inserted into a prepared root canal and secured using composite resin cement. Intended for use by dental professionals in a clinical setting. Provides structural reinforcement for the tooth restoration.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Carbon fiber material; root canal post form factor; used with composite resin cement; non-powered, passive dental device.

Indications for Use

Indicated for use in non-vital teeth requiring stabilization and support for a restoration via a prepared root canal.

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

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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and body.

#### Public Health Service

# MAY 1 7 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

J. Morita USA, Incorporated C/O Mr. Keith A. Barritt Fish & Richardson P.C. 601 13th Street, N.W. Washington, DC 20005

Re: K012496

Trade/Device Name: Carbon Post Regulation Number: 872.3810 Regulation Name: Root Canal Post Regulatory Class: I Product Code: ELR Dated: March 6, 2002 Received: March 7, 2002

### Dear Mr. Barritt:

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 - Mr. Barritt

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 (301) 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 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,

Patrice Cusenier/for

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): KO)Q496 Device Name: Carbon Post Indications For Use:

The Carbon Post is a root canal post for use with composite resin cement in a prepared root canal in a non-vital tooth to stabilize and support a restoration.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

Susan Ranns

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic F 11/9) Number _______________________________________________________________________________________________________________________________________________________________