LW Solid Abutment LWSA4537FC
LW Solid Abutment LWSA4537FC is a Class II device made by Ossvis Co., Ltd., cleared under FDA 510(k) K233167 on 25 Mar 2024 and listed in FDA GUDID since 20 May 2024 (UDI-DI 08809918213234), 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 | Number08809918213234 | Date20 May 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK233167 | Date25 Mar 2024 | StatusActive |
Official records
- AccessGUDID record 08809918213234
- FDA 510(k) database K233167
Across registries
- FDA 510(k) K233167 decided 25 Mar 2024 Active
- FDA GUDID UDI-DI 08809918213234 listed 20 May 2024 Listed
Timeline
- Cleared FDA 510(k) K233167
- Listed FDA GUDID 08809918213234
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- LW Solid Abutment
- Generic name
- Screw endosteal dental implant, two-piece
- Model / reference
- LWSA4537FC
- Primary DI / UDI-DI
- 08809918213234
- 510(k) Number
- FDA product code
- NHA
- GMDN term
- Screw endosteal dental implant, two-piece
- Device class
- Class II
- Regulation number
- 872.3630
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- MRI safety
- MR Conditional
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