CYTOPLAST GBR

K964342 · Osteogenics Co. · LYC · Mar 11, 1997 · Dental

Device Facts

• Record ID: K964342
• Device Name: CYTOPLAST GBR
• Applicant: Osteogenics Co.
• Product Code: LYC · Dental
• Decision Date: Mar 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects.

Device Story

Cytoplast™ GBR is a non-absorbable barrier membrane; composed of nanoporous high-density polytetrafluoroethylene (n-PTFE) film; 250-micron nominal thickness. Used in dental surgery to facilitate bone regeneration by acting as a space-making barrier over periodontal defects. Supplied sterile in various shapes/sizes. Implanted by clinicians; provides physical barrier to prevent soft tissue ingrowth into bone defect sites; promotes bone healing. Biocompatibility established via history of PTFE use in vascular/cardiovascular implants.

Clinical Evidence

No clinical data provided; substantial equivalence based on identical composition and function to predicate devices and established biocompatibility of PTFE material.

Technological Characteristics

Material: Nanoporous high-density polytetrafluoroethylene (n-PTFE) film. Dimensions: 250-micron nominal thickness. Form factor: Various shapes/sizes. Sterilization: Sterile. Energy source: None (passive implant).

Indications for Use

Indicated for patients requiring space-making barriers for the treatment of periodontal defects.

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

• Gore-Tex™ Regenerative Material (K922627)
• TefGen-FD (K935137)
• Imtec Biobarrier Membrane (K950306)

Submission Summary (Full Text)

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K964342

MAR 11 1997

# 510(k) SUMMARY

## I. ADMINISTRATIVE

Submitter: Osteogenics Co.
3234 64th Street
Lubbock, TX 79413
[phone]

Contact Person: Barry K. Bartee, DDS

Date of Preparation: January 29, 1997

## II. DEVICE NAME

Proprietary Name: Cytoplast™ GBR

Common Name: Non-Absorbable Barrier Membrane

Classification Name: Implant, Endosseous For Bone Filling And/Or Augmentation.

## III. PREDICATE DEVICES

Gore-Tex™ Regenerative Material (K922627; W.L Gore & Associates, Inc.)
TefGen-FD (K935137; American Custom Medical)
Imtec Biobarrier Membrane (K950306; Imtec Corporation)

## IV. DEVICE DESCRIPTION

The Cytoplast™ GBR Non-Absorbable Barrier Membrane is composed of nanoporous high density polytetrafluoroethylene (n-PTFE) film with a nominal thickness of 250 microns and supplied in a variety of shapes and sizes. Membranes are supplied sterile in sealed pouches.

The biocompatibility of polytetrafluoroethylene (PTFE) has been established through a long history of use in a variety of long-term PTFE implant devices, such as PTFE vascular prostheses and cardiovascular patches. The Cytoplast™ GBR Non-Absorbable Barrier Membrane has been shown to be non-cytotoxic.

## V. INTENDED USE

A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects.

K964342 Amendment: Cytoplast™ GBR

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# VI. COMPARISON TO PREDICATE DEVICES

The Cytoplast™ GBR Non-Absorbable Barrier Membrane is identical in composition, function, and intended use to legally marketed predicate devices such as Gore-Tex™ Regenerative Material, TefGen-FD, and the Imtec Biobarrier Membrane.

Accordingly, Osteogenics Co. concluded that the Cytoplast™ GBR Non - Absorbable Barrier Membrane is safe and effective for its intended use and performs at least as well as the legally marketed predicate devices.

K964342 Amendment: Cytoplast™ GBR