PERMAMESH-D HYDROXYLAPATITE MATRIX

K960361 · Ceramed Corp. · LYC · Apr 15, 1996 · Dental

Device Facts

• Record ID: K960361
• Device Name: PERMAMESH-D HYDROXYLAPATITE MATRIX
• Applicant: Ceramed Corp.
• Product Code: LYC · Dental
• Decision Date: Apr 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Bone filling and/or augmentation of the alveolar ridge.

Device Story

PermaMesh-D is a synthetic hydroxylapatite bone graft material; composed of high-purity, radiopaque, 1000-micron diameter beads; organized into a flat, flexible, cloth-like woven sheet using absorbable suture. Device serves as a scaffold for bone filling and augmentation of the alveolar ridge. Implanted by clinicians during surgical procedures to support bone regeneration.

Clinical Evidence

No clinical data provided; substantial equivalence based on material composition and physical characteristics.

Technological Characteristics

Material: 100% synthetic hydroxylapatite (HA) beads. Conforms to ASTM F1185 for trace elements. Calcium to phosphorus mole ratio: 1.68. Form factor: woven sheet/cloth-like structure held by absorbable suture. Radiopaque.

Indications for Use

Indicated for patients requiring bone filling or augmentation of the alveolar ridge.

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

• PermaRidge
• PermaMesh

Submission Summary (Full Text)

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510(k) SUMMARY
K960361 APR 15 1996
K960361

January 22, 1996

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

1. **Submitter:**
CeraMed Corporation
12860 West Cedar Drive
Lakewood, CO 80228
[phone]
Contact Person: Barbara A. Watson

2. **Device Name:**
PermaMesh-D Hydroxylapatite Matrix, 1000 microns
Classification Name: Endosseous implant for bone filling and/or augmentation

3. **Predicate Device:**
PermaRidge
PermaMesh

4. **Device Description:**
PermaMesh-D is a synthetic form of hydroxylapatite, the major mineral component of tooth enamel and bone, produced in the form of a woven sheet. It is manufactured as high purity, radiopaque, rounded particles sized at 1000 microns diameter and organized into a flat, flexible clothlike form by means of absorbable suture.

5. **Intended Use:**
Bone filling and/or augmentation of the alveolar ridge.

6. **Comparison of Product Characteristics:**
PermaMesh-D consists of 100% synthetic hydroxylapatite beads strung on absorbable suture.

X-ray diffraction shows PermaMesh-D beads to be 100% HA. The hydroxylapatite component of PermaMesh-D conforms to ASTM Standard # F1185, "Standard Specification for Composition of Ceramic Hydroxylapatite for Surgical Implants", for trace elements. Typical calcium to phosphorus mole ratio is 1.68.