Hydroflex
510(k) K970656
Hydroflex is a medical device (FDA Class II; FDA product code ELW, Material, Impression) made by Gc America Inc., cleared under FDA 510(k) K970656 on 8 Apr 1997, 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 | NumberK970656 | Date8 Apr 1997 | StatusActive |
Official records
- FDA 510(k) database K970656
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ELW
- FDA applicant
- GC America, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3660
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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