MEDENTiKA E 8101
MEDENTiKA E 8101 is a Class II device made by MEDENTiKA GmbH, cleared under FDA 510(k) K223113 on 15 Apr 2024 and listed in FDA GUDID since 1 May 2024 (UDI-DI 04251574850171), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04251574850171 | Date1 May 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK223113 | Date15 Apr 2024 | StatusActive |
Official records
- AccessGUDID record 04251574850171
- FDA 510(k) database K223113
Across registries
- FDA 510(k) K223113 decided 15 Apr 2024 Active
- FDA GUDID UDI-DI 04251574850171 listed 1 May 2024 Listed
Timeline
- Cleared FDA 510(k) K223113
- Listed FDA GUDID 04251574850171
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MEDENTiKA
- Generic name
- Dental implant suprastructure, permanent, preformed
- Model / Ref / Catalog
- E 8101
- Primary DI / UDI-DI
- 04251574850171
- 510(k) Number
- FDA product code
- NHA
- GMDN term
- Dental implant suprastructure, permanent, preformed
- Device class
- Class II
- Regulation number
- 872.3630
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- MRI safety
- MR Conditional
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