GC Fuji Direct
510(k) K172382
GC Fuji Direct is a Class II device made by Gc America Inc., cleared under FDA 510(k) K172382 on 2 Apr 2018, 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 | NumberK172382 | Date2 Apr 2018 | StatusActive |
Official records
- FDA 510(k) database K172382
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- Withdrawn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 K172382
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® 009293 | 009293 / 009293 | D0470092931 | — | On the market |
| GC Fuji® 012712 | 012712 / 012712 | D0470127121 | — | On the market |
| GC Fuji® 012712 | 012712 / 012712 | 14548161321969 | — | On the market |
| GC Fuji® 012713 | 012713 / 012713 | D0470127131 | — | On the market |
| GC Fuji® 012713 | 012713 / 012713 | 14548161321976 | — | On the market |
| GC Fuji® 012714 | 012714 / 012714 | D0470127141 | — | On the market |
| GC Fuji® 012714 | 012714 / 012714 | 14548161321983 | — | On the market |
| GC Fuji® 444001 | 444001 / 444001 | D0474440011 | Total Volume 7.2 mL | On the market |
| GC Fuji® 444001 | 444001 / 444001 | 10386040012508 | Total Volume 7.2 mL | On the market |
| GC Fuji® 444001 | 444001 / 444001 | D6584440011 | Total Volume 7.2 mL | On the market |
| GC Fuji® 444002 | 444002 / 444002 | D0474440021 | Total Volume 7.2 mL | On the market |
| GC Fuji® 444002 | 444002 / 444002 | 10386040012515 | Total Volume 7.2 mL | On the market |
| GC Fuji® 444002 | 444002 / 444002 | D6584440021 | Total Volume 7.2 mL | On the market |
| GC Fuji® 444003 | 444003 / 444003 | 10386040012522 | Total Volume 7.2 mL | On the market |
| GC Fuji® 444003 | 444003 / 444003 | D6584440031 | Total Volume 7.2 mL | On the market |
| GC Fuji® 444003 | 444003 / 444003 | D0474440031 | Total Volume 7.2 mL | On the market |
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