Coe Soft
510(k) K070697
Coe Soft is a Class II device made by Gc America Inc., cleared under FDA 510(k) K070697 on 29 Mar 2007, 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 | FDA 510(k)SESE | NumberK070697 | Date29 Mar 2007 | StatusActive |
Official records
- FDA 510(k) database K070697
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EBI
- FDA applicant
- GC America, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3760
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K070697
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| COE-SOFT™ 344001 | 344001 / 344001 | 10386040000345 | — | On the market |
| COE-SOFT™ 344002 | 344002 / 344002 | 10386040003704 | — | On the market |
| COE-SOFT™ 344003 | 344003 / 344003 | 00386040003714 | Weight 5 lb | On the market |
| COE-SOFT™ 344003 | 344003 / 344003 | D6583440031 | Weight 5 lb | On the market |
| COE-SOFT™ 344004 | 344004 / 344004 | D6583440041 | Weight 5 lb | On the market |
| COE-SOFT™ 344004 | 344004 / 344004 | 10386040006996 | Weight 5 lb | On the market |
| COE-SOFT™ 344011 | 344011 / 344011 | 10386040007016 | — | On the market |
| COE-SOFT™ 344011 | 344011 / 344011 | D6583440111 | — | On the market |
| COE-SOFT™ 344022 | 344022 / 344022 | 10386040007023 | Weight 156 g | On the market |
| COE-SOFT™ 344022 | 344022 / 344022 | D6583440221 | Weight 156 g | On the market |
| COE-SOFT™ 344033 | 344033 / 344033 | D6583440331 | Total Volume 5.5 Fluid Ounce | On the market |
| COE-SOFT™ 344033 | 344033 / 344033 | 10386040007030 | Total Volume 5.5 Fluid Ounce | On the market |
| COE-SOFT™ 344091 | 344091 / 344091 | 10386040003728 | — | On the market |
| COE-SOFT™ 344092 | 344092 / 344092 | 10386040007047 | Total Volume 1 Quart | On the market |
| COE-SOFT™ 344092 | 344092 / 344092 | D6583440921 | Total Volume 1 Quart | On the market |
| COE-SOFT™ 344094 | 344094 / 344094 | D6583440941 | — | On the market |
| COE-SOFT™ 344094 | 344094 / 344094 | 10386040003735 | — | On the market |
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