Equator Replacement Male 378050 V4
Equator Replacement Male 378050 V4 is a Class II device made by BIO CONCEPT Co., Ltd., cleared under FDA 510(k) K192274 on 18 Jun 2020 and listed in FDA GUDID since 16 Jul 2020 (UDI-DI 06947600313656), 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 | Number06947600313656 | Date16 Jul 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK192274 | Date18 Jun 2020 | StatusActive |
Official records
- AccessGUDID record 06947600313656
- FDA 510(k) database K192274
Across registries
- FDA 510(k) K192274 decided 18 Jun 2020 Active
- FDA GUDID UDI-DI 06947600313656 listed 16 Jul 2020 Listed
Timeline
- Cleared FDA 510(k) K192274
- Listed FDA GUDID 06947600313656
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Equator Replacement Male
- Generic name
- Dental implant system
- Model / reference
- 378050 V4
- Primary DI / UDI-DI
- 06947600313656
- 510(k) Number
- FDA product code
- NHA
- GMDN term
- Dental implant system
- Device class
- Class II
- Regulation number
- 872.3630
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Dental implant system.