AnyOne Internal Fixture IF3511
AnyOne Internal Fixture IF3511 is a Class II device made by Megagen Implant Co. Ltd, cleared under FDA 510(k) K123988 on 15 Aug 2013 and listed in FDA GUDID since 26 Jun 2015 (UDI-DI 08806388220656), 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 | Number08806388220656 | Date26 Jun 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK123988 | Date15 Aug 2013 | StatusActive |
Official records
- AccessGUDID record 08806388220656
- FDA 510(k) database K123988
Across registries
- FDA 510(k) K123988 decided 15 Aug 2013 Active
- FDA GUDID UDI-DI 08806388220656 listed 26 Jun 2015 Listed
Timeline
- Cleared FDA 510(k) K123988
- Listed FDA GUDID 08806388220656
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- AnyOne Internal Fixture
- Generic name
- Screw endosteal dental implant, two-piece
- Model / Ref / Catalog
- IF3511
- Description
- AnyOne Internal Ø3.5/ L=11.5
- Primary DI / UDI-DI
- 08806388220656
- 510(k) Number
- FDA product code
- DZE
- GMDN term
- Screw endosteal dental implant, two-piece
- Device class
- Class II
- Regulation number
- 872.3640
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
Similar devices in this category
Other devices filed under Screw endosteal dental implant, two-piece.