Fuji IX Gp
510(k) K961448
Fuji IX Gp is a Class II device made by Gc America Inc., cleared under FDA 510(k) K961448 on 8 Jul 1996, 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 | NumberK961448 | Date8 Jul 1996 | StatusActive |
Official records
- FDA 510(k) database K961448
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- Withdrawn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 K961448
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 IX GP® 425060 | 425060 / 425060 | D6584250601 | — | On the market |
| GC Fuji IX GP® 425060 | 425060 / 425060 | 10386040008952 | — | On the market |
| GC Fuji IX GP® 425061 | 425061 / 425061 | 10386040008969 | — | On the market |
| GC Fuji IX GP® 425061 | 425061 / 425061 | D6584250611 | — | On the market |
| GC Fuji IX GP® 425062 | 425062 / 425062 | D6584250621 | — | On the market |
| GC Fuji IX GP® 425062 | 425062 / 425062 | 10386040008976 | — | On the market |
| GC Fuji IX GP® 425063 | 425063 / 425063 | D6584250631 | — | On the market |
| GC Fuji IX GP® 425063 | 425063 / 425063 | 10386040008983 | — | On the market |
| GC Fuji IX GP® 425064 | 425064 / 425064 | 10386040008990 | — | On the market |
| GC Fuji IX GP® 425064 | 425064 / 425064 | D6584250641 | — | On the market |
| GC Fuji IX GP® 425065 | 425065 / 425065 | D6584250651 | — | On the market |
| GC Fuji IX GP® 425065 | 425065 / 425065 | 10386040009003 | — | On the market |
| GC Fuji IX GP® 425066 | 425066 / 425066 | D6584250661 | — | On the market |
| GC Fuji IX GP® 425066 | 425066 / 425066 | 10386040009010 | — | On the market |
| GC Fuji IX GP® 425070 | 425070 / 425070 | D6584250701 | — | On the market |
| GC Fuji IX GP® 425070 | 425070 / 425070 | 10386040009027 | — | On the market |
| GC Fuji IX GP® 425080 | 425080 / 425080 | D6584250801 | — | On the market |
| GC Fuji IX GP® 425080 | 425080 / 425080 | 10386040009034 | — | On the market |
| GC Fuji IX GP® 425081 | 425081 / 425081 | 10386040009041 | — | On the market |
| GC Fuji IX GP® 425081 | 425081 / 425081 | D6584250811 | — | On the market |
| GC Fuji IX GP® 425082 | 425082 / 425082 | D6584250821 | — | On the market |
| GC Fuji IX GP® 425082 | 425082 / 425082 | 10386040009058 | — | On the market |
| GC Fuji IX GP® 425083 | 425083 / 425083 | D6584250831 | — | On the market |
| GC Fuji IX GP® 425083 | 425083 / 425083 | 10386040009065 | — | On the market |
| GC Fuji IX GP® 425084 | 425084 / 425084 | 10386040009072 | — | On the market |
| GC Fuji IX GP® 425084 | 425084 / 425084 | D6584250841 | — | On the market |
| GC Fuji IX GP® 425085 | 425085 / 425085 | D6584250851 | — | On the market |
| GC Fuji IX GP® 425085 | 425085 / 425085 | 10386040009089 | — | On the market |
| GC Fuji IX GP® 425090 | 425090 / 425090 | 10386040009096 | — | On the market |
| GC Fuji IX GP® 425090 | 425090 / 425090 | D6584250901 | — | On the market |
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