Coe-Soft™ 344004
Coe-Soft™ 344004 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K070697 on 29 Mar 2007 and listed in FDA GUDID since 1 Aug 2016 (UDI-DI D6583440041), 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 | NumberD6583440041 | Date1 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK070697 | Date29 Mar 2007 | StatusActive |
Official records
- FDA 510(k) database K070697
Across registries
- FDA 510(k) K070697 decided 29 Mar 2007 Active
- FDA GUDID UDI-DI D6583440041 listed 1 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K070697
- Listed FDA GUDID D6583440041
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Coe-Soft™
- Generic name
- Denture reliner, soft, professional
- Model / Ref / Catalog
- 344004
- Primary DI / UDI-DI
- D6583440041
- 510(k) Number
- FDA product code
- EBI
- GMDN term
- Denture reliner, soft, professional
- Device class
- Class II
- Regulation number
- 872.3760
- GUDID distribution status
- In Commercial Distribution
- Size
- Weight — 5 Pound
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