Nexplant IOP3215-40
by Achimhai Medical Corporation
Nexplant IOP3215-40 is a Class II device made by Achimhai Medical Corporation, cleared under FDA 510(k) K170394 on 6 Oct 2017 and listed in FDA GUDID since 1 Jun 2018 (UDI-DI 08800024913599), 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 | Number08800024913599 | Date1 Jun 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK170394 | Date6 Oct 2017 | StatusActive |
Official records
- AccessGUDID record 08800024913599
- FDA 510(k) database K170394
Across registries
- FDA 510(k) K170394 decided 6 Oct 2017 Active
- FDA GUDID UDI-DI 08800024913599 listed 1 Jun 2018 Listed
Timeline
- Cleared FDA 510(k) K170394
- Listed FDA GUDID 08800024913599
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Nexplant
- Generic name
- Screw endosteal dental implant, one-piece
- Model / Ref / Catalog
- IOP3215-40
- Primary DI / UDI-DI
- 08800024913599
- 510(k) Number
- FDA product code
- DZE
- GMDN term
- Screw endosteal dental implant, one-piece
- Device class
- Class II
- Regulation number
- 872.3640
- GUDID distribution status
- In Commercial Distribution