SNUCONE Tissue Level Implant System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K222792 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)
The SNUCONE Tissue Level Implant System is a dental implant designed for osseointegration within the alveolar bone. It is classified as a tissue-level dental implant, featuring a platform-switching design to promote bone preservation and stability around the implant-abutment interface.
This system is supplied sterile and intended for single-use in oral and maxillofacial surgical procedures. It is regulated under the FDA’s 510(k) pathway with a Traditional clearance (K222792) and complies with the Medical Device Directive (MDD). The product is available in various sizes and configurations as specified in the device documentation, with no MRI safety restrictions noted.
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 (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K222792 | Class II | Active |
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Manufacturer
- Manufacturer
- SNUCONE Co., LTD.
Sources (2)
- FDA 510(k) K222792 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026