The following data is part of a premarket notification filed by Gc America Inc. with the FDA for Aadva Zr Coloring Liquid.
| Device ID | K092020 |
| 510k Number | K092020 |
| Device Name: | AADVA ZR COLORING LIQUID |
| Classification | Powder, Porcelain |
| Applicant | GC AMERICA INC. 3737 WEST 127TH STREET Alsip, IL 60803 |
| Contact | Mark Heiss |
| Correspondent | Mark Heiss GC AMERICA INC. 3737 WEST 127TH STREET Alsip, IL 60803 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-06 |
| Decision Date | 2009-09-29 |
| Summary: | summary |