The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Gcuc-505.
| Device ID | K091388 |
| 510k Number | K091388 |
| Device Name: | GCUC-505 |
| Classification | Material, Tooth Shade, Resin |
| 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 | EBF |
| Subsequent Product Code | EBC |
| Subsequent Product Code | LBH |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-11 |
| Decision Date | 2009-07-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14548161323345 | K091388 | 000 |
| 14548161323208 | K091388 | 000 |
| 14548161323215 | K091388 | 000 |
| 14548161323222 | K091388 | 000 |
| 14548161323239 | K091388 | 000 |
| 14548161323246 | K091388 | 000 |
| 14548161323253 | K091388 | 000 |
| 14548161323260 | K091388 | 000 |
| 14548161323277 | K091388 | 000 |
| 14548161323284 | K091388 | 000 |
| 14548161323291 | K091388 | 000 |
| 14548161323307 | K091388 | 000 |
| 14548161323314 | K091388 | 000 |
| 14548161323321 | K091388 | 000 |
| 14548161323338 | K091388 | 000 |
| 14548161323192 | K091388 | 000 |