SynOss Synthetic Bone Graft Material
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K072397 FDA 510(k)
- FDA Product Code
- LYC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3930 FDA 510(k)
- Regulation Number
- 872.3930 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
SynOss Synthetic Bone Graft Material is a calcium phosphate-based, osteoconductive bone graft designed for dental applications. It mimics the apatite structure of human bone, providing a scaffold to support new bone formation in surgical procedures. The material is intended for use in alveolar ridge augmentation, sinus floor elevation, and periodontal defect filling.
Supplied as sterile, non-pyrogenic granules for single-use, this device is regulated under FDA 510(k) clearance (K072397) and classified as a Class II medical device. It is intended exclusively for dental surgical applications, with no indication of MRI compatibility or reusable design. Storage and handling must adhere to sterile medical device protocols.
Frequently asked questions
What is SynOss Synthetic Bone Graft Material used for in dental procedures?
SynOss Synthetic Bone Graft Material is specifically designed for dental surgical applications, including alveolar ridge augmentation, sinus floor elevation, and filling periodontal defects. Its calcium phosphate composition mimics the apatite structure of natural bone, providing an osteoconductive scaffold that supports new bone growth in these critical areas. This makes it ideal for procedures requiring bone regeneration to prepare sites for dental implants or restore lost bone volume.
How is SynOss Synthetic Bone Graft Material supplied, and is it reusable?
SynOss Synthetic Bone Graft Material is supplied as sterile, non-pyrogenic granules in single-use packaging. This ensures safety and consistency for each surgical procedure, as reuse is not recommended or intended. The sterile presentation aligns with standard medical device protocols to prevent contamination and maintain efficacy.
What storage and handling precautions should be taken with SynOss?
Since SynOss is a sterile medical device, it must be stored and handled according to sterile medical device protocols. This includes keeping the packaging intact until use, storing in a clean, dry environment away from direct sunlight or extreme temperatures, and following manufacturer guidelines to preserve sterility. Improper storage could compromise the material’s integrity and safety for surgical use.
Is SynOss compatible with MRI imaging, and can it be used in any surgical setting?
The device data does not mention MRI compatibility, so there is no indication that SynOss Synthetic Bone Graft Material is safe or effective for use in MRI environments. Its intended use is exclusively for dental surgical procedures, such as ridge augmentation or sinus lifts, where bone regeneration is required. Always verify compatibility with imaging modalities based on specific clinical needs and device labeling.
What distinguishes SynOss from other bone graft materials in dental applications?
SynOss is distinguished by its calcium phosphate-based composition, which closely resembles the apatite structure of human bone. This composition provides osteoconductive properties, meaning it supports the growth of new bone cells along its surface. Unlike some natural or synthetic alternatives, SynOss is specifically formulated for dental use—particularly alveolar ridge augmentation, sinus floor elevation, and periodontal defect filling—making it a targeted solution for these procedures.
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. Sources consulted: SynOss™ Synthetic Mineral Bone - OsseoDent™, SYNOSS SYNTHETIC BONE GRAFT MATERIAL - Innolitics, Collagen Matrix, Inc. Receives FDA 510(k) Clearance for SynOss(TM ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K072397 | Class II | Active |
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Manufacturer
- Manufacturer
- Collagen Matrix, Inc.
Sources (1)
- FDA 510(k) K072397 24 fields · synced Oct 1, 2026