Identifiers
- 510(k) Number
- K062051 FDA 510(k)
- FDA Product Code
- DZE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3640 FDA 510(k)
- Regulation Number
- 872.3640 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Ss System by Osstem Implant Co., Ltd. — Class II — listed in FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (0 countries)
Regulatory Authorizations
No authorizations listed.
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Manufacturer
- Manufacturer
- Osstem Implant Co., Ltd.
Sources (1)
- FDA 510(k) K062051 24 fields · synced Jun 19, 2026