Identity
- Trade Name
- GEM 21S (GROWTH-FACTOR ENHANCED MATRIX FDA PMA
- Generic Name
- Bone grafting material, dental, with biologic component FDA PMA
Identifiers
- PMA Number
- P040013 FDA PMA
- FDA Product Code
- NPZ FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 872.3930 FDA PMA
- Regulation Number
- 872.3930 FDA PMA
- Advisory Committee
- Dental FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The GEM 21S Growth Factor Enhance Matrix is a bone grafting material, dental, with biologic component, classified as a Class III device. It is designed to promote tissue regeneration in periodontally related defects, including intrabony, furcation, and gingival recession sites associated with periodontal disease. The matrix incorporates growth factors to enhance bone and soft tissue integration, supporting periodontal repair and regeneration.
This device is supplied as a sterile, single-use material intended for surgical use in dental procedures. It is regulated under FDA PMA approval (P040013) and falls under the product code NPZ, adhering to regulatory standards for dental bone grafting materials. Storage and handling must comply with sterile medical device protocols to ensure efficacy and safety in periodontal defect treatment.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P040013 | Class III | Active |
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Manufacturer
- Manufacturer
- Lynch Biologics, Llc
Sources (1)
- FDA PMA P040013 24 fields · synced Sep 18, 2026