RESOLUT REGENERATIVE MATERIAL

K962624 · W. L. Gore & Associates, Inc. · LYC · Oct 3, 1996 · Dental

Device Facts

• Record ID: K962624
• Device Name: RESOLUT REGENERATIVE MATERIAL
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: LYC · Dental
• Decision Date: Oct 3, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

RESOLUT Regenerative Material is a bioabsorbable, implantable material intended to aid in the healing of periodontal defects. It may also be used as a membrane for bone graft containment. When used over a bone graft, RESOLUT Regenerative Material provides a stable barrier to graft material migration and provides a favorable environment for healing.

Device Story

Bioabsorbable implantable material; composed of porous glycolide polymer fiber structure and occlusive glycolide/lactide copolymer membrane. Surgically placed beneath muco-periosteum by dental clinicians. Functions as guided tissue regeneration (GTR) barrier; inhibits epithelial migration; isolates periodontal defects from gingival connective tissue; provides spacemaking and graft containment. Benefits patient by facilitating bone/periodontal ligament regeneration and stabilizing graft materials during wound healing.

Clinical Evidence

Preclinical study in canine mandibular defects; demonstrated device efficacy as a membrane for bone graft containment and ability to provide a favorable environment for bone regeneration, comparable to CAPSET Calcium Sulfate Bone Graft Barrier.

Technological Characteristics

Bioabsorbable synthetic glycolide polymer fiber (porous structure) and glycolide/lactide copolymer (occlusive membrane). Biocompatible, cell-occlusive, spacemaking design. Implantable form factor.

Indications for Use

Indicated for patients requiring regenerative healing of bone/periodontal ligament defects of the oral cavity; used as a barrier membrane to aid healing or to prevent migration of bone graft material.

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

• RESOLUT Regenerative Material (K962624)
• CAPSET Calcium Sulfate Bone Graft Barrier
• Micro Titanium Augmentation Mesh

Submission Summary (Full Text)

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OCT - 3 1996
K962624

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

1. **Applicant Name, Address:** W.L. Gore & Associates, Inc.
1500 North Fourth Street
P.O. Box 2500
Flagstaff, AZ 86003-2500

**Contact Person, Telephone:** Jacqueline Kalbach
[phone]

**Date of Summary:** July 3, 1996

2. **Classification Name:** Resorbable Barrier Membrane
**Common or Usual Name:** Regenerative Material
**Proprietary Name:** RESOLUT Regenerative Material

3. **Predicate Device** RESOLUT Regenerative Material, CAPSET
Calcium Sulfate Bone Graft Barrier, and Micro Titanium Augmentation Mesh.

4. **Device Description:**

RESOLUT Regenerative Material is composed of a porous structure of synthetic bioabsorbable glycolide polymer fiber and an occlusive membrane of synthetic bioabsorbable glycolide and lactide copolymer. The porous structure is designed to attach to surrounding soft tissue and inhibit epithelial migration, while the occlusive membrane isolates the periodontal defect from gingival connective tissue during wound healing. RESOLUT Regenerative Material has been designed to act in accordance with the accepted principles of wound healing and guided tissue regeneration (GTR). Specifically, the device is designed to be biocompatible, cell occlusive, spacemaking, and clinically manageable, and allow for tissue integration.

RESGRAFT
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RESOLUT Regenerative Material, K962624
October 2, 1996

RESOLUT Regenerative Material is surgically placed beneath the muco-periosteum to aid in the regenerative healing of bone/periodontal ligament defects of the oral cavity or, when placed over bone graft material, to prevent graft material migration.

## 5. Intended Use:

RESOLUT Regenerative Material is a bioabsorbable, implantable material intended to aid in the healing of periodontal defects. It may also be used as a membrane for bone graft containment. When used over a bone graft, RESOLUT Regenerative Material provides a stable barrier to graft material migration and provides a favorable environment for healing.

## 6. Technological Characteristics:

RESOLUT Regenerative Material has been designed to act in accordance with the accepted principles of wound healing and guided tissue regeneration (GTR). Specifically, the device is designed to be biocompatible, cell occlusive, spacemaking, and clinically manageable, and allow for tissue integration.

## 7. Assessment of Performance Data:

A preclinical study in canine mandibular defects demonstrates that RESOLUT Regenerative Material can be used as a membrane to contain bone grafting materials. Like CAPSET Calcium Sulfate Bone Graft Barrier, it can provide a favorable environment for bone regeneration.

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8. Conclusion:

There have been no changes to RESOLUT Regenerative Material in terms of its design, manufacturing process, materials, and intended use. The modifications to the indications for use are substantially equivalent to the indications for use of CAPSET Calcium Sulfate Barrier Graft, Micro Titanium Augmentation Mesh, and the predicate RESOLUT Regenerative Material.

RESGRAFT