Chaorum Implant System ASFS3612S
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08806394607601 | Date31 Aug 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK160536 | Date5 Jan 2017 | StatusActive |
Official records
- AccessGUDID record 08806394607601
- FDA 510(k) database K160536
Recalls
No FDA recalls found in the data synced 23 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Chaorum Implant System
- Generic name
- Dental implant system
- Model / reference
- ASFS3612S
- Primary DI / UDI-DI
- 08806394607601
- 510(k) Number
- FDA product code
- DZE
- GMDN term
- Dental implant system
- Device class
- Class II
- Regulation number
- 872.3640
- GUDID distribution status
- In Commercial Distribution
Other devices from Medimecca Co., Ltd.
Properties
Other properties (8)
- Sterilise before use: No
- Contains latex: No
- Over-the-counter: No
- Convenience kit: No
- Combination product: No
- HCT/P: No
- Premarket exempt: No
- Serial number: No