INFIBRA, MODEL 1200

K061735 · Global Dental Products, Inc. · EBI · Sep 8, 2006 · Dental

Device Facts

• Record ID: K061735
• Device Name: INFIBRA, MODEL 1200
• Applicant: Global Dental Products, Inc.
• Product Code: EBI · Dental
• Decision Date: Sep 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended 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.

Device Story

InFibra is a fiber reinforcement material composed of braided ultra-high-molecular-weight polyethylene (UHMW) fibers. It is used by dentists in clinical settings to strengthen acrylic or composite resins during the fabrication or repair of dental prostheses and appliances. The material is integrated into the resin matrix to enhance structural integrity and load-carrying capacity. By providing reinforcement, the device improves the durability of dentures, bridges, night-guards, and splints, potentially reducing the risk of fracture and extending the functional life of the dental restoration for the patient.

Clinical Evidence

Bench testing only. Cytotoxicity testing per ISO 10993-5 showed no evidence of cytotoxic response. Mechanical testing per ISO 3597-2 (three-point bending) confirmed suitability for reinforcing dentures, bridges, splints, and orthodontic appliances.

Technological Characteristics

Material: Braided ultra-high-molecular-weight polyethylene (UHMW) fibers. Mechanical testing conducted per ISO 3597-2. Biocompatibility testing conducted per ISO 10993-5. Device is a fiber reinforcement material for dental resins.

Indications for Use

Indicated for use by dentists to reinforce acrylic or composite resins in dental restorations, including full/partial dentures, overdentures, night-guards, orthodontic appliances, temporary/permanent bonded and removable bridges, and splints for tooth immobilization.

Regulatory Classification

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.

Predicate Devices

• Ribbond TM (K913040)
• EZ Connect (K000346)

Submission Summary (Full Text)

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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 [e-mail]

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 [phone]. 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 [phone] or [phone] 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):

K061735

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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