EXAlence™ 137570
EXAlence™ 137570 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K041398 on 25 Jun 2004 and listed in FDA GUDID since 1 Aug 2016 (UDI-DI D6581375701), active (FDA 510(k)), not in commercial distribution (GUDID) 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 | NumberD6581375701 | Date1 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK041398 | Date25 Jun 2004 | StatusActive |
Official records
- FDA 510(k) database K041398
Across registries
- FDA 510(k) K041398 decided 25 Jun 2004 Active
- FDA GUDID UDI-DI D6581375701 listed 1 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K041398
- Listed FDA GUDID D6581375701
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- EXAlence™
- Generic name
- Silicone dental impression material
- Model / Ref / Catalog
- 137570
- Primary DI / UDI-DI
- D6581375701
- 510(k) Number
- FDA product code
- ELW
- GMDN term
- Silicone dental impression material
- Device class
- Class II
- Regulation number
- 872.3660
- GUDID distribution status
- Not in Commercial Distribution
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