(80 days)
Infibra is intended for use by dentists to provide reinforcement to acrylic or composite resins used for dental restorations. It can be used for the following applications: As reinforcement in manufacturing and/or repairing full or partial dentures as well as overdentures, night-guards and orthodontic appliances. To repair and reinforce resin or composite prostheses including temporary and permanent bonded and removable bridges. To reinforce splints used to immobilize teeth.
InFibra is a fiber reinforcement used to reinforce dental resins. It is made of ultra-high-molecularweight polyethylene (UHMW). The fibers are braided and not leno-weave treated.
The device in question, InFibra, is a fiber reinforcement material for dental resins. The provided text is a 510(k) summary and associated FDA correspondence, not a detailed study report for a medical AI device. Therefore, much of the requested information regarding AI-specific acceptance criteria and study details (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance of an algorithm, etc.) is not applicable or available in this document.
However, I can extract the acceptance criteria and performance relevant to this material science device based on the provided FDA submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Biocompatibility: ISO 10993-5 "Biological evaluation of medical devices - Tests for cytotoxicity: in vitro methods" | "show no evidence of cytotoxic response" |
| Mechanical Strength: ISO 3597-2 (Three-point Bending standards) | "The results showed the material to be suitable for reinforcing 1) removable dentures 2) crown and bridges 3) provisional crown and bridges 4) splint device reinforcement 2) splinting of teeth 6) orthodontic appliances" |
| Comparison to Predicate: Substantial equivalence in quality of mechanical characteristics, mechanical safety, materials, design, performance, and indication for use with Ribbond™ (K913040) and EZ Connect (K000346). | "InFibra is made of UHMW fiber braided. Tests show that InFibra has greater load carrying capacity than the leno-weave. The different design characteristics of InFibra are primary differences of minor changes to the materials and dimensions and does not raise new questions of safety and effectiveness and demonstrates that the device is as safe and effective as the predicate device." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified (implied to be laboratory testing for material properties).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as this is a material science device, not an AI diagnostic device. Ground truth is established by standardized laboratory tests.
4. Adjudication method for the test set
- Not applicable. Performance is determined by quantitative measurements against ISO standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI device.
7. The type of ground truth used
- For biocompatibility: In vitro cytotoxicity test results based on ISO 10993-5.
- For mechanical properties: Quantitative measurements (e.g., load carrying capacity) based on ISO 3597-2.
- For substantial equivalence: Comparison against the characteristics and performance of legally marketed predicate devices.
8. The sample size for the training set
- Not applicable. This is a material science device, not an AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
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K061735
p. 1 of 1
Section E: 510(K) Summary
ﺎ
Applicant: Bioloren sas Via Prealpi, 44 21047 Saronno VA Italv Phone +39 - 02 - 96703261 Fax +39 - 02 - 96703261 E-mail bioloren@tiscali.it
SEP = 8 2006
Andrea Ratti Contact person :
Device Trade Name InFibra
Fiber reinforcement material Device Common Name
Device Classification Name Class II - Denture realigning, repairing or rebasing resin (CFR 872.3760)
Product code: EBI
Description of Device
InFibra is a fiber reinforcement used to reinforce dental resins. It is made of ultra-high-molecularweight polyethylene (UHMW). The fibers are braided and not leno-weave treated.
Performance Standards & Testings
Standard ISO 10993 - 5 "Biological evaluation of medical devices - Tests for cytoxicity: in vitro methods" was conducted and show no evidence of 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 reinforcing 1) removable dentures 2) crown and bridges 3) provisional crown and bridges 4) splint device reinforcement 2) splinting of teeth 6) orthodontic appliances
Other mechanical tests were conducted to characterize the material.
Predicate device - Substantial Equivalency
The modified is substantially equivalent to the previously Ribbond TM (K 913040 date 7 October 1991) and EZ Connect (K 000346)
The modified device is substantially equivalent in quality of mechanical characteristics, of mechanical safety, of materials, of design, of performance and of indication for use.
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Description of new characteristics
InFibra is made of UHMW fiber braided. Tests show that InFibra has greater load carrying capacity than the leno-weave.
The different design characteristics of InFibra are primary differences of minor changes to the ﺘﻬﻢ ﺍﻟﻤﺴﺘﻘﺒﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ materials and dimensions and does not raise new questions of safety and effectiveness and i demonstrates that the device is as safe and effective as the predicate device.
There are no new hazards presented with InFibra as with the predicate device.
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Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
SEP = 8 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bioloren sas C/O Mr. Jerry Bartick President Global Dental Products, Incorporated 1028 Mclean Avenue Wantagh, New York 11793
Re: K061735
Trade/Device Name: InFibra Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: June 10, 2006 Received: June 20, 2006
Dear Mr. Bartick:
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.
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Page 2 - Mr. Bartick
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. 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
Shin Lin, Ph.D.
Chiu Lin, Ph.D. 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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Indications for Use
510(k) Number (if known):
Device Name: Infibra
Indications for Use:
Infibra is intended for use by dentists to provide reinforcement to acrylic or composite resins used for dental restorations. It can be used for the following applications:
As reinforcement in manufacturing and/or repairing full or partial dentures as well as overdentures, night-guards and orthodontic appliances.
To repair and reinforce resin or composite prostheses including temporary and permanent bonded and removable bridges.
To reinforce splints used to immobilize teeth. Prescription Use X
(21 CFR Part 801 Subpart D )
(21 CFR Part 807 Subpart C )
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Dunne
്ഥന Sign-Off) sion of Anesthesiology, General Hospital, Control, Dental Devices
Number: K06173
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.