Gc Gam-100
510(k) K073283
Gc Gam-100 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K073283 on 20 Feb 2008, 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 | NumberK073283 | Date20 Feb 2008 | StatusActive |
Official records
- FDA 510(k) database K073283
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EMA
- FDA applicant
- GC America, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3275
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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