SuperLine II FXS4507C
by Dentium USA
SuperLine II FXS4507C is a Class II device made by Dentium USA, cleared under FDA 510(k) K213599 on 23 Feb 2022 and listed in FDA GUDID since 31 Jan 2023 (UDI-DI D755FXS4507C0), 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 | NumberD755FXS4507C0 | Date31 Jan 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK213599 | Date23 Feb 2022 | StatusActive |
Official records
- FDA 510(k) database K213599
Across registries
- FDA 510(k) K213599 decided 23 Feb 2022 Active
- FDA GUDID UDI-DI D755FXS4507C0 listed 31 Jan 2023 Listed
Timeline
- Cleared FDA 510(k) K213599
- Listed FDA GUDID D755FXS4507C0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SuperLine II
- Generic name
- Screw endosteal dental implant, two-piece
- Model / Ref / Catalog
- FXS4507C
- Primary DI / UDI-DI
- D755FXS4507C0
- 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
- Size
- Outer Diameter — 4.5 MillimeterLength — 7 Millimeter
Similar devices in this category
Other devices filed under Screw endosteal dental implant, two-piece.