Gc Fuji Temp
510(k) K101420
Gc Fuji Temp is a Class II device made by Gc America Inc., cleared under FDA 510(k) K101420 on 17 Sep 2010, 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 | NumberK101420 | Date17 Sep 2010 | StatusActive |
Official records
- FDA 510(k) database K101420
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- Withdrawn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 K101420
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 TEMP LT™ 004253 | 004253 / 004253 | D0470042531 | Weight 13.3 g | On the market |
| GC Fuji TEMP LT™ 004253 | 004253 / 004253 | 14548161282536 | Weight 13.3 g | On the market |
| GC Fuji TEMP LT™ 437855 | 437855 / 437855 | D6584378551 | — | On the market |
| GC Fuji TEMP LT™ 437855 | 437855 / 437855 | 10386040009393 | — | On the market |
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Other devices filed under FDA product code EMA (Cement, Dental).
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- CHELON-FIL by Espe GmbH (Us)