Fuji I
510(k) K980695
Fuji I is a Class II device made by Gc America Inc., cleared under FDA 510(k) K980695 on 13 Apr 1998, 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 | NumberK980695 | Date13 Apr 1998 | StatusActive |
Official records
- FDA 510(k) database K980695
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- Withdrawn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
Devices cleared under K980695
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 | |||
|---|---|---|---|---|
| GC Fuji I® 425095 | 425095 / 425095 | D6584250951 | On the market | |
| GC Fuji I® 425095 | 425095 / 425095 | 10386040009102 | On the market | |
| GC Fuji I® 901007 | 901007 / 901007 | J0229010071 | On the market | |
| GC Fuji I® 901007 | 901007 / 901007 | 15400556014056 | On the market | |
| GC Fuji I® 901008 | 901008 / 901008 | J0229010081 | On the market | |
| GC Fuji I® 901008 | 901008 / 901008 | 15400556014063 | On the market | |
| GC Fuji I® 901009 | 901009 / 901009 | 15400556014070 | On the market | |
| GC Fuji I® 901009 | 901009 / 901009 | J0229010091 | On the market |
Similar devices
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- EDS Universal Cement by Essential Dental Systems
- DYRACT CEM PLUS CEMENT by Dentsply Intl.