Fusion Fast
510(k) K043471
Fusion Fast is a Class II device made by Gc America Inc., cleared under FDA 510(k) K043471 on 27 Jan 2005, 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 | NumberK043471 | Date27 Jan 2005 | StatusActive |
Official records
- FDA 510(k) database K043471
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- Withdrawn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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