(145 days)
Not Found
No
The summary describes a physical dental post made of glass fiber composite and mentions standard biological and mechanical testing. There is no mention of software, algorithms, image processing, or terms related to AI/ML.
No
The device is described as a composite post intended to retain reconstruction of non-vital teeth and support restorations. It is structural and supportive, but does not actively treat a disease or condition in a therapeutic manner.
No
Explanation: The device is a dental post used for structural support in restorations, not for diagnosing medical conditions.
No
The device description explicitly states it is a "Glass Fiber composite root canal post," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide retention for reconstruction of non-vital teeth by being cemented into the root canal. This is a therapeutic or restorative function performed directly on the patient's tooth.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not involve testing samples from the body.
- Device Description: The device is a glass fiber composite root canal post, which is a physical implant/restorative material.
- Anatomical Site: The device is used within the root canal of a tooth, which is part of the patient's anatomy, not a sample taken from the body.
The information provided clearly describes a medical device used for treatment and restoration within the body, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for 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.
Product codes
76 ELR, ELR
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canal of a tooth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentists
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K012354, K945370, K000311, K983266, K003221
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3810 Root canal post.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
JUL 3 2002
510(k) SUMMARY (As required by 21 C.F.R. 807.92)
| Date : | December 18, 2001 | |
|---|---|---|
| Submitter : | ANTHOGYR | |
| 164, rue des 3 lacs | ||
| 74700 Sallanches - FRANCE | ||
| Tel : 33 (0)4 50 58 02 37 | ||
| Fax : 33 (0)4 50 93 78 60 | ||
| Establishment registration number : #8020776 | ||
| Contact | CHAIRMAN AND MANAGING DIRECTOR : Mr Claude ANTHOINE | |
| Tel : 33 (0)4 50 58 02 37 | ||
| E-Mail : prod@anthogyr.com | ||
| 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.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally oriented. The words are stacked on top of each other.
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.
Image /page/1/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white and appears to be a scanned image.
2
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 (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
3
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