LS Block LBI12A3
by Genoss
LS Block LBI12A3 is a Class II device made by Genoss, cleared under FDA 510(k) K160144 on 21 Jul 2016 and listed in FDA GUDID since 10 Jul 2018 (UDI-DI 08809552964455), 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 | Number08809552964455 | Date10 Jul 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK160144 | Date21 Jul 2016 | StatusActive |
Official records
- AccessGUDID record 08809552964455
- FDA 510(k) database K160144
Across registries
- FDA 510(k) K160144 decided 21 Jul 2016 Active
- FDA GUDID UDI-DI 08809552964455 listed 10 Jul 2018 Listed
Timeline
- Cleared FDA 510(k) K160144
- Listed FDA GUDID 08809552964455
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- LS Block
- Generic name
- Dental appliance fabrication material, ceramic
- Model / Ref / Catalog
- LBI12A3
- Primary DI / UDI-DI
- 08809552964455
- 510(k) Number
- FDA product code
- EIH
- GMDN term
- Dental appliance fabrication material, ceramic
- Device class
- Class II
- Regulation number
- 872.6660
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Radiation Sterilization
- Size
- Length — 12 Millimeter
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