rainbow LS Block
510(k) K160144
rainbow LS Block is a Class II device made by GENOSS CO., Ltd., cleared under FDA 510(k) K160144 on 21 Jul 2016, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK160144 | Date21 Jul 2016 | StatusActive |
Official records
- FDA 510(k) database K160144
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EIH
- Device class
- Class II
- Regulation
- 21 CFR Part 872.6660
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K160144
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| LS Block LBC14A1 | LBC14A1 / LBC14A1 | 08809552964523 | Length 15 mm | On the market |
| LS Block LBC14A2 | LBC14A2 / LBC14A2 | 08809552964530 | Length 15 mm | On the market |
| LS Block LBC14A3 | LBC14A3 / LBC14A3 | 08809552964547 | Length 15 mm | On the market |
| LS Block LBC14A3.5 | LBC14A3.5 / LBC14A3.5 | 08809552964554 | Length 15 mm | On the market |
| LS Block LBC14A4 | LBC14A4 / LBC14A4 | 08809552964561 | Length 15 mm | On the market |
| LS Block LBC14B1 | LBC14B1 / LBC14B1 | 08809552964578 | Length 15 mm | On the market |
| LS Block LBC14B2 | LBC14B2 / LBC14B2 | 08809552964585 | Length 15 mm | On the market |
| LS Block LBC14B3 | LBC14B3 / LBC14B3 | 08809552964592 | Length 15 mm | On the market |
| LS Block LBC14B4 | LBC14B4 / LBC14B4 | 08809552964608 | Length 15 mm | On the market |
| LS Block LBI12A1 | LBI12A1 / LBI12A1 | 08809552964431 | Length 12 mm | On the market |
| LS Block LBI12A2 | LBI12A2 / LBI12A2 | 08809552964448 | Length 12 mm | On the market |
| LS Block LBI12A3 | LBI12A3 / LBI12A3 | 08809552964455 | Length 12 mm | On the market |
| LS Block LBI12A3.5 | LBI12A3.5 / LBI12A3.5 | 08809552964462 | Length 12 mm | On the market |
| LS Block LBI12A4 | LBI12A4 / LBI12A4 | 08809552964479 | Length 12 mm | On the market |
| LS Block LBI12B1 | LBI12B1 / LBI12B1 | 08809552964486 | Length 12 mm | On the market |
| LS Block LBI12B2 | LBI12B2 / LBI12B2 | 08809552964493 | Length 12 mm | On the market |
| LS Block LBI12B3 | LBI12B3 / LBI12B3 | 08809552964509 | Length 12 mm | On the market |
| LS Block LBI12B4 | LBI12B4 / LBI12B4 | 08809552964516 | Length 12 mm | On the market |
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