rainbow Block W9812
by Genoss
rainbow Block W9812 is a Class II device made by Genoss, cleared under FDA 510(k) K092513 on 9 Oct 2009 and listed in FDA GUDID since 23 Sep 2019 (UDI-DI 08809324768380), 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 | Number08809324768380 | Date23 Sep 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK092513 | Date9 Oct 2009 | StatusActive |
Official records
- AccessGUDID record 08809324768380
- FDA 510(k) database K092513
Across registries
- FDA 510(k) K092513 decided 9 Oct 2009 Active
- FDA GUDID UDI-DI 08809324768380 listed 23 Sep 2019 Listed
Timeline
- Cleared FDA 510(k) K092513
- Listed FDA GUDID 08809324768380
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- rainbow Block
- Generic name
- Dental appliance fabrication material, ceramic
- Model / Ref / Catalog
- W9812
- Primary DI / UDI-DI
- 08809324768380
- 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
- Size
- Height — 12 Millimeter
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