ArgenIS AngBase AO 4.5/5.0
ArgenIS AngBase AO 4.5/5.0 (127511) is a Class II device made by Argen Corporation, the, cleared under FDA 510(k) K173908 on 15 Jun 2018 and listed in FDA GUDID since 1 Feb 2023 (UDI-DI D818127511), active as of 22 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 | NumberD818127511 | Date1 Feb 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK173908 | Date15 Jun 2018 | StatusActive |
Official records
- FDA 510(k) database K173908
Across registries
- FDA 510(k) K173908 decided 15 Jun 2018 Active
- FDA GUDID UDI-DI D818127511 listed 1 Feb 2023 Listed
Timeline
- Cleared FDA 510(k) K173908
- Listed FDA GUDID D818127511
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ArgenIS
- Generic name
- Dental implant suprastructure, permanent, preformed
- Model / Ref / Catalog
- AngBase AO 4.5/5.0, 127511
- Primary DI / UDI-DI
- D818127511
- 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 Safe