The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Gc Opb-100.
| Device ID | K080724 |
| 510k Number | K080724 |
| Device Name: | GC OPB-100 |
| Classification | Adhesive, Bracket And Tooth Conditioner, 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 | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-14 |
| Decision Date | 2008-06-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D6584394661 | K080724 | 000 |
| 10386040009836 | K080724 | 000 |
| 10386040009829 | K080724 | 000 |
| 14548161072632 | K080724 | 000 |