The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Gc Fuji Temp.
| Device ID | K101420 |
| 510k Number | K101420 |
| Device Name: | GC FUJI TEMP |
| Classification | Cement, Dental |
| Applicant | GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Contact | Mark Heiss |
| Correspondent | Mark Heiss GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-20 |
| Decision Date | 2010-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10386040009393 | K101420 | 000 |
| 14548161282536 | K101420 | 000 |