Chang's DA-vich Deep Dentin D Dark 15ml
Chang's DA-vich Deep Dentin D Dark 15ml (Deep Dentin D Dark 15ml) is a Class II device made by U&C International Co., Ltd, cleared under FDA 510(k) K191902 on 11 Oct 2019 and listed in FDA GUDID since 9 Mar 2022 (UDI-DI 08800118622420), 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 | Number08800118622420 | Date9 Mar 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK191902 | Date11 Oct 2019 | StatusActive |
Official records
- AccessGUDID record 08800118622420
- FDA 510(k) database K191902
Across registries
- FDA 510(k) K191902 decided 11 Oct 2019 Active
- FDA GUDID UDI-DI 08800118622420 listed 9 Mar 2022 Listed
Timeline
- Cleared FDA 510(k) K191902
- Listed FDA GUDID 08800118622420
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Chang's DA-vich
- Generic name
- Dental appliance fabrication material, ceramic
- Model / reference
- Deep Dentin D Dark 15ml
- Primary DI / UDI-DI
- 08800118622420
- 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