Angled Abutment (Hex) HISA40325
by InnoBioSurg Co., Ltd(IBS implant Co., Ltd)
Angled Abutment (Hex) HISA40325 is a Class II device made by InnoBioSurg Co., Ltd(IBS implant Co., Ltd), cleared under FDA 510(k) K153350 on 9 May 2016 and listed in FDA GUDID since 16 Nov 2018 (UDI-DI 08800039305051), 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 | Number08800039305051 | Date16 Nov 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK153350 | Date9 May 2016 | StatusActive |
Official records
- AccessGUDID record 08800039305051
- FDA 510(k) database K153350
Across registries
- FDA 510(k) K153350 decided 9 May 2016 Active
- FDA GUDID UDI-DI 08800039305051 listed 16 Nov 2018 Listed
Timeline
- Cleared FDA 510(k) K153350
- Listed FDA GUDID 08800039305051
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Angled Abutment (Hex)
- Generic name
- Dental implant system
- Model / reference
- HISA40325
- Primary DI / UDI-DI
- 08800039305051
- 510(k) Number
- FDA product code
- NHA, DZE
- GMDN term
- Dental implant system
- Device class
- Class II
- Regulation number
- 872.3630, 872.3640
- GUDID distribution status
- In Commercial Distribution
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