Identifiers
- 510(k) Number
- K172354 FDA 510(k)
- FDA Product Code
- JEY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.4760 FDA 510(k)
- Regulation Number
- 872.4760 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The OssBuilder System is a non-absorbable, pre-formed titanium mesh membrane engineered for guided bone regeneration. It maintains graft volume and fits various defect geometries without trimming, delivering stable scaffold support for vertical and horizontal ridge reconstruction.
The system is supplied as a kit and is intended for use in dental procedures. It is a single-use device and is not MRI safe. The OssBuilder System has received FDA 510(k) clearance with the product code JEY and is classified as a class II device.
Frequently asked questions
What is the OssBuilder System used for?
The OssBuilder System is a non-absorbable titanium mesh membrane designed for guided bone regeneration in dental procedures. It maintains graft volume and provides stable scaffold support for vertical and horizontal ridge reconstruction.
How is the OssBuilder System supplied?
The system is supplied as a kit specifically for dental procedures. It is a single-use device and is not MRI safe, meaning it should not be used in patients undergoing MRI scans.
What is the regulatory status of the OssBuilder System?
The OssBuilder System has received FDA 510(k) clearance with product code JEY and is classified as a class II device. It is substantially equivalent to other devices intended for the same purpose.
Can the OssBuilder System be trimmed to fit different defect geometries?
No, the OssBuilder System is pre-formed and designed to fit various defect geometries without trimming, making it convenient for different dental reconstruction procedures while maintaining graft volume.
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 Surgical Manual OssBuilder KIT - osstem.eu, OssBuilder - Osstem Europe, Osstem Implant, Osstem Implant
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172354 | Class II | Active |
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Manufacturer
- Manufacturer
- Osstem Implant Co., Ltd.
Sources (1)
- FDA 510(k) K172354 24 fields · synced Sep 26, 2026