The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Gc Models Opa-100 And Jc-50.
| Device ID | K073588 |
| 510k Number | K073588 |
| Device Name: | GC MODELS OPA-100 AND JC-50 |
| 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 | Yes |
| Date Received | 2007-12-20 |
| Decision Date | 2008-02-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D6584394871 | K073588 | 000 |
| 10386040015271 | K073588 | 000 |
| 10386040015288 | K073588 | 000 |
| 14548161331982 | K073588 | 000 |
| 14548161331999 | K073588 | 000 |
| 14548161332002 | K073588 | 000 |
| 14548161293921 | K073588 | 000 |
| 14548161293938 | K073588 | 000 |
| 14548161293945 | K073588 | 000 |
| 14548161293952 | K073588 | 000 |
| 10386040009843 | K073588 | 000 |
| D0470135711 | K073588 | 000 |
| D0470135721 | K073588 | 000 |
| D0470135731 | K073588 | 000 |
| D0470031031 | K073588 | 000 |
| D0470031021 | K073588 | 000 |
| D0470031051 | K073588 | 000 |
| 10386040015264 | K073588 | 000 |