FIBIOCORE

K020431 · Est. Anthogyr · ELR · Jul 3, 2002 · Dental

Device Facts

• Record ID: K020431
• Device Name: FIBIOCORE
• Applicant: Est. Anthogyr
• Product Code: ELR · Dental
• Decision Date: Jul 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3810
• Device Class: Class 1

Intended Use

The FIBIOCORE composite posts are intented for use by dentists to give retention for reconstruction of non-vital teeth. The device is intended to be cemented into the root canal of a tooth to stabilize and support a restoration.

Device Story

FIBIOCORE is a glass fiber composite root canal post; used by dentists to provide retention for reconstruction of non-vital teeth. The post is cemented into the root canal to stabilize and support dental restorations. Device functions as a mechanical support structure for tooth reconstruction. No complex electronics, software, or automated processing involved.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993-5 (cytotoxicity) showed no evidence of cytotoxic response. Mechanical testing performed in conformance with ISO 3597-2 (three-point bending) confirmed suitability for root canal post application.

Technological Characteristics

Glass fiber composite root canal post. Mechanical properties characterized via ISO 3597-2 three-point bending standards. Biocompatibility verified via ISO 10993-5. Passive mechanical device; no energy source, connectivity, or software.

Indications for Use

Indicated for use by dentists to provide retention for the reconstruction of non-vital teeth by stabilizing and supporting a restoration.

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.

Predicate Devices

• Carbotech Snowpost (K012354)
• Bisco UM Aesthetic Post (K945370)
• Coltene ParaPost Fiber White (K000311)
• Jeneric/Pentron FibreKor Post (K983266)
• Harald Nordin Glassix post (K003221)

Submission Summary (Full Text)

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JUL 3 2002

K020431

# 510(k) SUMMARY (As required by 21 C.F.R. 807.92)

| Date : | December 18, 2001 | |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Submitter : | ANTHOGYR<br>164, rue des 3 lacs<br>74700 Sallanches - FRANCE<br>Tel : [phone]<br>Fax : [phone]<br>Establishment registration number : #8020776 | |
| Contact | CHAIRMAN AND MANAGING DIRECTOR : Mr Claude ANTHOINE<br>Tel : [phone]<br>E-Mail : [e-mail] | |
| Device Name | | |
| | Proprietary Name : | FIBIOCORE |
| | Device Trade name : | FIBIOCORE |
| | Common/Usual Name : | Glass Fiber composite root canal post |
| | Proposed Classification Name : | Dental root canal post |
| Device Classification | | |
| | Class : | I |
| | Classification Regulation : | 21 CFR 872.3810 |
| | Product Code : | 76 ELR |
| Performance Standards & Testing | | |

Standard ISO 10993-5 "Biological evaluation of medical devices - Tests for Cytotoxicity : in vitro methods" was conducted and shows no evidence of a cytotoxic response. Mechanical tests were conducted in conformance with ISO 3597-2 (Three-point Bending Standards). The results showed the material to be suitable for root canal posts. Others Mechanical tests were conducted to characterize the material.

#### Predicate Device - Substantial Equivalence

The modified device is substantially equivalent to the previously cleared Carbotech Snowpost (K012354), Bisco UM Aesthetic Post (K945370), Coltene ParaPost Fiber White (K000311), Jeneric/Pentron FibreKor Post (K983266), and the Harald Nordin Glassix post (K003221) devices.

The modified device is substantially equivalent in quality of mechanical characteristics, of mechanical safety, of materials, of design, of performance and of indications for use.

#### Modifications

The primary differences are minor changes to the material and dimensions.

### Intended Use of the subject Devices

The modified device has the same intended use as the legally marketed predicate devices herein referenced. The FIBIOCORE composite posts are intented for use by dentists to give retention for reconstruction of non-vital teeth. The device is intended to be cemented into the root canal of a tooth to stabilize and support a restoration.

### Technological Characteristics

The modified device has the same technological characteristics as the leggaly marketed predicate device mechanically supporting reconstruction.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### 3 2002 JUL

Mr. Claude Anthoine Est. ANTHOGYR Chairman and Managing Director 164 Rue Des 3 Lacs 74700 Sallanches, FRANCE

Re: K020431

Trade/Device Name: FIBIOCORE Glass Fiber Composite Posts Regulation Number: 872.3810 Regulation Name: Root Canal Post Regulatory Class: I Product Code: ELR Dated: May 9, 2002 Received: May 9, 2002

Dear Mr. Anthoine:

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. Anthoine

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,

Timothy A. Ulatowski

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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K 020431

# INDICATIONS FOR USE STATEMENT

510(k) Number : (if known)

Device Name: FIBIOCORE Glass Fiber composite posts

The FIBIOCORE composite posts are intented for use by dentists Indications For Use : to give retention for reconstruction of non-vital teeth.

## PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use __

Susan Purrp

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices CATOR 510(k) Number