LW Solid Abutment SET LWSA5014RS
LW Solid Abutment SET LWSA5014RS is a Class II device made by Ossvis Co., Ltd., cleared under FDA 510(k) K231079 on 14 Sep 2023 and listed in FDA GUDID since 20 Dec 2023 (UDI-DI 08809918231238), 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 | Number08809918231238 | Date20 Dec 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK231079 | Date14 Sep 2023 | StatusActive |
Official records
- AccessGUDID record 08809918231238
- FDA 510(k) database K231079
Across registries
- FDA 510(k) K231079 decided 14 Sep 2023 Active
- FDA GUDID UDI-DI 08809918231238 listed 20 Dec 2023 Listed
Timeline
- Cleared FDA 510(k) K231079
- Listed FDA GUDID 08809918231238
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- LW Solid Abutment SET
- Generic name
- Screw endosteal dental implant, two-piece
- Model / reference
- LWSA5014RS
- Primary DI / UDI-DI
- 08809918231238
- 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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