The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Gc Fuji Ix Gp Extra.
| Device ID | K070319 |
| 510k Number | K070319 |
| Device Name: | GC FUJI IX GP EXTRA |
| Classification | Cement, Dental |
| Applicant | GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Contact | Terry L Joritz-lyons |
| Correspondent | Terry L Joritz-lyons GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2007-02-02 |
| Decision Date | 2007-02-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386040008948 | K070319 | 000 |
| 00386040008863 | K070319 | 000 |
| 00386040008870 | K070319 | 000 |
| 00386040008887 | K070319 | 000 |
| 00386040008894 | K070319 | 000 |
| 00386040008900 | K070319 | 000 |
| 00386040008917 | K070319 | 000 |
| 00386040008924 | K070319 | 000 |
| 00386040008931 | K070319 | 000 |
| 00386040008856 | K070319 | 000 |