Synthograft Tricalcium Phosphate-Ceramic
FDA PMAClass II (US FDA PMA)
by curasan AG
Identity
- Trade Name
- PERI-OSS FDA PMA
- Generic Name
- Bone grafting material, for dental bone repair FDA PMA
Identifiers
- PMA Number
- P800035 FDA PMA
- FDA Product Code
- LPK FDA PMA
Classification
- Advisory Committee
- Dental FDA PMA
- FDA Decision
- APRL FDA PMA
The Synthograft Tricalcium Phosphate-Ceramic is a bone grafting material designed for dental bone repair. Classified as a synthetic bone substitute, it is composed of tricalcium phosphate ceramic, providing a scaffold to support new bone formation in oral and maxillofacial applications.
This material is supplied as a sterile, resorbable ceramic for single-use in surgical procedures. It is intended for use in dental settings, where it aids in reconstructing bone defects following extractions, sinus lifts, or ridge augmentation. The product is authorised under FDA PMA (P800035) and adheres to dental regulatory standards for bone graft substitutes.
Frequently asked questions
What types of dental procedures is this bone grafting material specifically designed for?
This Synthograft Tricalcium Phosphate-Ceramic is designed for dental bone repair procedures such as reconstructing bone defects after extractions, sinus lifts, or ridge augmentation. It acts as a scaffold to support new bone growth in oral and maxillofacial applications.
Is this product reusable or intended for single-use only?
The Synthograft Tricalcium Phosphate-Ceramic is explicitly supplied as a sterile, resorbable ceramic intended for single-use in surgical procedures. Reuse is not recommended or supported by the manufacturer.
How is this bone grafting material packaged and stored?
While specific packaging details aren’t provided, the product is described as sterile and designed for surgical use, implying it is likely supplied in sealed, sterile packaging. Storage should follow standard sterile medical device protocols to maintain integrity until use.
What regulatory pathway was followed for FDA authorization of this device?
The Synthograft Tricalcium Phosphate-Ceramic was authorized under the FDA PMA (Premarket Approval) process, with the approval number P800035. This pathway is typically used for higher-risk medical devices, confirming its compliance with rigorous regulatory standards.
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 | P800035 | Class II | Active |
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Manufacturer
- Manufacturer
- curasan AG
Sources (1)
- FDA PMA P800035 24 fields · synced Sep 18, 2026