SwissGraft X Bone Grafting Material
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K251613 FDA 510(k)
- FDA Product Code
- NPM 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)
SwissGraft X is a bone grafting material of animal origin, designed to support bone regeneration in dental procedures. It is classified as a bone graft substitute, providing a scaffold to enhance osseous integration and promote healing in extraction sockets, ridge preservation, and sinus augmentation.
The material is supplied in sterile, single-use formats and is intended for use in dental settings. It is classified under FDA device class 2 and has received Special 510(k) clearance for dental applications. Various particle sizes are available, and the product is regulated under the FDA’s regulation number 872.3930, ensuring compliance with dental regenerative standards.
Frequently asked questions
What types of dental procedures is SwissGraft X intended to support during bone regeneration?
SwissGraft X is specifically designed to support bone regeneration in dental procedures such as extraction sockets, ridge preservation, and sinus augmentation. It acts as a scaffold to enhance osseous integration and promote healing in these areas, helping to maintain or restore bone structure where needed.
Is SwissGraft X available in multiple particle sizes, and why might this matter for clinicians?
Yes, SwissGraft X is supplied in various particle sizes, which allows clinicians to select the most appropriate granularity for the specific procedure. Larger particles may be better suited for sinus lifts or ridge augmentation, while finer particles could be ideal for smaller extraction sockets or precise grafting tasks, ensuring optimal integration and healing outcomes.
How is SwissGraft X supplied, and what does this mean for its handling and storage?
SwissGraft X is supplied in sterile, single-use formats, meaning each package is intended for one-time use only. This ensures sterility and reduces the risk of contamination, while also simplifying storage—clinicians only need to keep unopened packages in a clean, dry environment until use, as no reprocessing is required.
What regulatory pathway did SwissGraft X follow to gain market authorization in the U.S., and what does this imply about its safety and effectiveness?
SwissGraft X received Special 510(k) clearance from the FDA under classification II, indicating it was determined to be *substantially equivalent* to a legally marketed predicate device. This pathway confirms the product meets FDA standards for safety, performance, and intended use in dental bone grafting, though it does not imply approval for specific clinical outcomes—only that it complies with regulatory requirements for its designated applications.
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: PDF Geistlich SwissGraft® X Geistlich SwissMembrane®, K251613 FDA 510(k) - SwissGraft X | Geistlich Pharma AG, Geistlich Pharma International - Geistlich Pharma AG, Geistlich expands its range of technologies and ventures into new ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251613 | Class II | Active |
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Manufacturer
- Manufacturer
- Geistlich Pharma AG
Sources (1)
- FDA 510(k) K251613 24 fields · synced Sep 20, 2026