Essential Dustless alginate 1127285
Essential Dustless alginate 1127285 is a Class II device made by Henry Schein, Inc., cleared under FDA 510(k) K011785 on 4 Sep 2001 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00304040018712), 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 | Number00304040018712 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK011785 | Date4 Sep 2001 | StatusActive |
Official records
- AccessGUDID record 00304040018712
- FDA 510(k) database K011785
Across registries
- FDA 510(k) K011785 decided 4 Sep 2001 Active
- FDA GUDID UDI-DI 00304040018712 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K011785
- Listed FDA GUDID 00304040018712
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Essential Dustless alginate
- Generic name
- Alginate dental impression material
- Model / Ref / Catalog
- 1127285
- Primary DI / UDI-DI
- 00304040018712
- 510(k) Number
- FDA product code
- ELW
- GMDN term
- Alginate dental impression material
- Device class
- Class II
- Regulation number
- 872.3660
- GUDID distribution status
- In Commercial Distribution
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