Iso Functional Sticks 000043
Iso Functional Sticks 000043 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K022430 on 18 Oct 2002 and listed in FDA GUDID since 1 Aug 2016 (UDI-DI D0470000431), 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 | GUDID listing | NumberD0470000431 | Date1 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK022430 | Date18 Oct 2002 | StatusActive |
Official records
- FDA 510(k) database K022430
Across registries
- FDA 510(k) K022430 decided 18 Oct 2002 Active
- FDA GUDID UDI-DI D0470000431 listed 1 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K022430
- Listed FDA GUDID D0470000431
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Iso Functional Sticks
- Generic name
- Composite dental impression material
- Model / Ref / Catalog
- 000043
- Primary DI / UDI-DI
- D0470000431
- 510(k) Number
- FDA product code
- ELW
- GMDN term
- Composite dental impression material
- Device class
- Class II
- Regulation number
- 872.3660
- GUDID distribution status
- In Commercial Distribution
- Size
- Weight — 8 Gram
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