The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Fuji Ix Gp.
| Device ID | K961448 |
| 510k Number | K961448 |
| Device Name: | FUJI IX GP |
| Classification | Cement, Dental |
| Applicant | GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Contact | Terry L Joritz |
| Correspondent | Terry L Joritz 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 | 1996-04-16 |
| Decision Date | 1996-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D6584250901 | K961448 | 000 |
| D6584250611 | K961448 | 000 |
| D6584250621 | K961448 | 000 |
| D6584250631 | K961448 | 000 |
| D6584250641 | K961448 | 000 |
| D6584250651 | K961448 | 000 |
| D6584250661 | K961448 | 000 |
| D6584250701 | K961448 | 000 |
| D6584250801 | K961448 | 000 |
| D6584250811 | K961448 | 000 |
| D6584250821 | K961448 | 000 |
| D6584250831 | K961448 | 000 |
| D6584250841 | K961448 | 000 |
| D6584250851 | K961448 | 000 |
| D6584250601 | K961448 | 000 |