Identifiers
- 510(k) Number
- K220894 FDA 510(k)
- FDA Product Code
- MQC FDA 510(k)
Classification
- Device Class
- U FDA 510(k)
- Advisory Committee
- Unknown FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
SmileGuard by Envisiontec GmbH — U — MDR, FDA_510K — listed in FDA 510(k), EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
MDR
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | U | Active |
| FDA 510(k) | United States | FDA_510K | K220894 | U | Active |
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Manufacturer
- Manufacturer
- Envisiontec GmbH
Sources (2)
- FDA 510(k) K220894 24 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced May 19, 2026