GC FUJI ORTHO
Adhesive, Bracket And Tooth Conditioner, Resin
GC AMERICA, INC.
The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Gc Fuji Ortho.
Pre-market Notification Details
| Device ID | K961417 |
| 510k Number | K961417 |
| Device Name: | GC FUJI ORTHO |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Contact | Terry L Jortiz |
| Correspondent | Terry L Jortiz GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-12 |
| Decision Date | 1996-05-24 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190746007835 | K961417 | 000 |
| D8281330003 | K961417 | 000 |
| 20386040009864 | K961417 | 000 |
| 24548161293683 | K961417 | 000 |
| 24548161293676 | K961417 | 000 |
Trademark Results [GC FUJI ORTHO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GC FUJI ORTHO 78104099 2652064 Live/Registered |
TRADEMARK HOLDINGS OF ILLINOIS LLC 2002-01-22 |
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