IMTEC/BIOBARRIER MEMBRANE

K974752 · Imtec Corp. · NPK · Mar 3, 1998 · Dental

Device Facts

• Record ID: K974752
• Device Name: IMTEC/BIOBARRIER MEMBRANE
• Applicant: Imtec Corp.
• Product Code: NPK · Dental
• Decision Date: Mar 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

IMTEC BioBarrier is a temporarily implantable material intended to be used as a space maintaining barrier over bone. It is intended for use in the oral cavity. The material is conformable to a variety of shapes as required for specific anatomical limitations. The IMTEC BioBarrier is additionally indicated for: - simultaneous use of GBR-membrane (BioBarrier) and implants: - augmentation around implants placed in immediate extraction sockets; - augmentation around implants placed in delayed extraction sockets; - localized ridge augmentation for later implantation. Because of its elasticity, the IMTEC BioBarrier should be used in combination with space-making bone graft materials, e.g., autogenous bone or bone substitutes.

Device Story

IMTEC BioBarrier is a non-absorbable, 100% polytetrafluoroethylene (PTFE) membrane; acts as a passive mechanical barrier to prevent epithelial and gingival connective tissue migration into osseous cavities. Used in oral surgery; placed by dental clinicians over bone sites to facilitate guided bone regeneration (GBR). Requires use with space-making bone graft materials (e.g., autogenous bone or substitutes) due to material elasticity. Provides mechanical support for bone repair while maintaining tissue compliance. Benefits include improved bone regeneration outcomes in dental implant procedures. Device is sterile, available in porous (5u) or non-porous full-density forms, and can be trimmed to fit anatomical requirements.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Constructed of 100% polytetrafluoroethylene (PTFE). Available in porous (5 micron) or non-porous (full density) forms. Passive mechanical barrier; non-absorbable. Supplied sterile. Dimensions are variable/customizable by clinician.

Indications for Use

Indicated for patients requiring guided bone regeneration in the oral cavity, including augmentation around dental implants in immediate or delayed extraction sockets and localized ridge augmentation. Contraindicated in patients with local infection, vascular impairment, uncontrolled diabetes, chronic high-dose steroid use, clotting disorders, anticoagulant therapy, metabolic bone disease, or other systemic disorders affecting bone/wound healing. Not for use to stabilize failed implants.

Regulatory Classification

Identification

Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Special Controls

*Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• Bio-gide (K960724)

Submission Summary (Full Text)

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K974752

MAR - 3 1998

#### 510 (k) Summary

# SUBMITTED BY:

M. K. Patterson, Jr. PhD Sr Vice President Regulatory Affairs IMTEC Corporation 2401 North Commerce Ardmore, Oklahoma 73401 [phone]

F.D.A Registration Number: 1645158 Owner / Operator Number: 9003407

Date Submitted: December 20 ,1997

# CLASSIFICATION/COMMON OR USUAL NAME/ DEVICE NAME:

Classification Name: AUGMENTATION MEMBRANE, 76LYC. Common/ Usual Name: GUIDED TISSUE MEMBRANE, PTFE. Proprietary Name: IMTEC/ BIOBARRIER MEMBRANE (K950306 / K972240)

### PREDICATE DEVICE:

Osteohealth, Bio-gide, K960724

# DEVICE DESCRIPTION:

IMTEC/BIOBARRIER is a non-absorbable guided tissue membrane composed of 100% Polytetrafluoroethylene. It is provided in various dimensions and can be cut to a preferred shape or size The device will be marketed as a sterile device. It is available in either Porous (5 u) or Non-Porous, "full density" PTFE.

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# INDICATIONS FOR USE:

IMTEC BioBarrier is a temporarily implantable material intended to be used as a space maintaining barrier over bone. It is intended for use in the oral cavity. The material is conformable to a variety of shapes as required for specific anatomical limitations.

The IMTEC BioBarrier is additionally indicated for:

- simultaneous use of GBR-membrane (BioBarrier) and implants: -
- augmentation around implants placed in immediate extraction sockets; -
- augmentation around implants placed in delayed extraction sockets; -
- localized ridge augmentation for later implantation. 1

Because of its elasticity, the IMTEC BioBarrier should be used in combination with space-making bone graft materials, e.g., autogenous bone or bone substitutes.

## PRINCIPLES OF OPERATION:

IMTEC/ BIOBARRIER is manufactured from biocompatable,100% PTFE. It has been demonstrated to serve as a temporary mechanical barrier to undesirable tissue growth into an osseous cavity. It is designed to be a passive barrier which reduces the migration of epithelial and gingival connective tissue into a bony repair site. The material is firm enough to provide sufficient mechanical support over a site while maintaining adequately supple characteristics during placement such that tissue compliance related problems are reduced.

# CONTRAINDICATIONS:

It is critical that when used in dental implant repair applications that the implant is stable. It may NOT be used to stabilize a failed implant. Contraindications customary to the use of bone grafts and membrane techniques should be observed. These include, but are not limited to, current local infection, vascular impairment, uncontrolled diabetes, chronic high dose of steroids, clotting disorders, current anticoagulant therapy, etabolic bone disease, and other metabolic or systemic disorders which will affect bone or wound healing.

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# COMPLICATIONS:

Possible complications with any oral reconstructive surgery include infection, closure perforation, abcess formation, bone loss, pain, soft tissue irregularities, and additional complications associated with anesthesia and dental surgery. Specific to this surgery is augmentation material perforation or exfoliation. Depending on the type and severity of the complications the removal of the membrane may be indicated.

# MATERIALS OF CONSTRUCTION:

IMTEC/ BIOBARRIER is constructed of 100% polytetrafluoroethylene (PTFE).

# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

The uses of IMTEC/BIOBARRIER are similar to the currently marketed predicate devices which are used for Guided Bone Regeneration (GBR) in conjunction with endosseous dental implant placement and repair.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

OCT 1 0 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850

Mr. M.K. Patterson, Jr. Ph.D. Sr. Vice President Regulatory Affairs IMTEC Corporation 2401 North Commerce Ardmore, Oklahoma 73401

Re: K974752

Trade Name: Imtec/Biobarrier Membrane Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: 2 Product Code: NPK Dated: December 19, 1997 Received: December 19, 1997

Dear Dr. Patterson:

This letter corrects our substantially equivalent letter of March 3, 1998.

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 (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 additional controls. Existing major regulations affecting (1111), is may 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 -

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 continue 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/dsma/dsmamain.html

Sincerely yours,

Sattie Y. Michael Davis.

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

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Protecting and Promoting Public Health

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# 1974753

### 510(k) Number (if known):

#### IMTEC BIOBARRIER MEMBRANE Device Name:

### Indications For Use:

IMTEC BioBarrier is a temporarily implantable material intended to be used as a space maintaining barrier over bone. It is intended for use in the oral cavity. The material is conformable to a variety of shapes as required for specific anatomical limitations.

The IMTEC BioBarrier is additionally indicated for:

- simultancous use of GBR-membrane (BioBarrier) and implants:
- augmentation around implants placed in immediate extraction sockets;
- augmentation around implants placed in delayed extraction sockets;
- localized ridge augmentation for later implantation.

Because of its clasticity, the IMTEC BioBarrier should be used in combination with space-making bone graft malerials, e.g., autogenous bone or bone substitutes.

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF YEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susen Runner

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number 1974752

Prescription Use
(Per 21 CFR 801.109)
OR

Over-The-Counter Use

(Optional Format 1-2-96)