IU Cover Screw IUCSA
IU Cover Screw IUCSA is a Class II device made by WARANTEC.Co., Ltd, cleared under FDA 510(k) K172345 on 18 Jun 2018 and listed in FDA GUDID since 12 Apr 2023 (UDI-DI 08800026106500), 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 | Number08800026106500 | Date12 Apr 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK172345 | Date18 Jun 2018 | StatusActive |
Official records
- AccessGUDID record 08800026106500
- FDA 510(k) database K172345
Across registries
- FDA 510(k) K172345 decided 18 Jun 2018 Active
- FDA GUDID UDI-DI 08800026106500 listed 12 Apr 2023 Listed
Timeline
- Cleared FDA 510(k) K172345
- Listed FDA GUDID 08800026106500
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- IU Cover Screw
- Generic name
- Dental implant system
- Model / reference
- IUCSA
- Primary DI / UDI-DI
- 08800026106500
- 510(k) Number
- FDA product code
- DZE, NHA
- GMDN term
- Dental implant system
- Device class
- Class II
- Regulation number
- 872.3640, 872.3630
- GUDID distribution status
- In Commercial Distribution
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