Healing Abutment HAB452035L
by Dentium USA
Healing Abutment HAB452035L is a Class II device made by Dentium USA, cleared under FDA 510(k) K052957 on 27 Jul 2006 and listed in FDA GUDID since 29 Aug 2016 (UDI-DI D755HAB452035L0), 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 | NumberD755HAB452035L0 | Date29 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK052957 | Date27 Jul 2006 | StatusActive |
Official records
- FDA 510(k) database K052957
Across registries
- FDA 510(k) K052957 decided 27 Jul 2006 Active
- FDA GUDID UDI-DI D755HAB452035L0 listed 29 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K052957
- Listed FDA GUDID D755HAB452035L0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Healing Abutment
- Generic name
- Dental implant suprastructure, temporary, preformed, single-use
- Model / Ref / Catalog
- HAB452035L
- Primary DI / UDI-DI
- D755HAB452035L0
- 510(k) Number
- FDA product code
- NHA
- GMDN term
- Dental implant suprastructure, temporary, preformed, single-use
- 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
- Size
- Outer Diameter — 4.5 MillimeterLength — 10.9 Millimeter
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