(80 days)
K 913040, K 000346
Not Found
No
The device description and performance studies focus on the material properties and mechanical reinforcement capabilities of the fiber, with no mention of AI or ML.
No
The device is described as a fiber reinforcement used to reinforce dental resins in various dental restorations and appliances, such as dentures, bridges, and splints. Its purpose is to provide structural support and reinforcement, not to treat a disease, injury, or alleviate a condition.
No
The device, Infibra, is described as a fiber reinforcement used to strengthen dental resins for restorations and appliances. Its intended use focuses on providing structural support rather than diagnosing conditions.
No
The device description clearly states that InFibra is a fiber reinforcement made of ultra-high-molecularweight polyethylene (UHMW), which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Infibra is used by dentists to reinforce dental resins for restorations, dentures, bridges, splints, and orthodontic appliances. This is a therapeutic or restorative application, not a diagnostic one.
- Device Description: The description details the material and structure of the fiber reinforcement, which is consistent with a material used in dental procedures.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide information about a patient's health status or condition.
- Performance Studies: The performance studies focus on biocompatibility (cytotoxicity) and mechanical properties, which are relevant for a material used in the body, not for a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Infibra does not fit this description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EBI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K 913040, K 000346
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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.
イ
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.
1
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.
2
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
3
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
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