FIBREKOR POST SYSTEM

K983266 · Jeneric/Pentron, Inc. · ELR · Nov 9, 1998 · Dental

Device Facts

• Record ID: K983266
• Device Name: FIBREKOR POST SYSTEM
• Applicant: Jeneric/Pentron, Inc.
• Product Code: ELR · Dental
• Decision Date: Nov 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3810
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Reinforcement of an endodontically involved tooth Retention of Core and or Core Material

Device Story

Fibrekor Post System is a dental device used for the restoration of endodontically treated teeth. It functions as a post to provide structural reinforcement to the tooth root and serves as an anchor for core buildup materials. The device is intended for use by dental professionals in a clinical setting. By providing internal support, it aids in the reconstruction of teeth that have lost significant structure due to decay or trauma, facilitating the placement of final restorations like crowns.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental post system for endodontic restoration. Specific materials, dimensions, and manufacturing standards are not detailed in the provided documentation.

Indications for Use

Indicated for the reinforcement of endodontically treated teeth and the retention of core materials.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 9 1998

Mr. Murray G. Gamberg Quality System Director Jeneric®/Pentron®, Incorporated 53 North Plains Industrial Road P.O. Box 724 Wallingford, Connecticut 06492-0724

K983266 Re: Fibrekor Post System Trade Name: Regulatory Class: I Product Code: ELR September 14, 1998 Dated: September 17, 1998 Received:

Dear Mr. Gamberg:

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) regulation (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 regulation 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Gamberg

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 qeneral 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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| 510(k) Number (if known): | K983266 |
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## Device Name:FIBREKOR POST SYSTEM ™

Indications For Use:

Reinforcement of an endodontically involved tooth

Retention of Core and or Core Material

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

Concurrence of CDRH, Office of Device Evaluation (ODE) OR Prescription Use Over-the-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number