The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for G-bond Plus.
| Device ID | K082768 |
| 510k Number | K082768 |
| Device Name: | G-BOND PLUS |
| Classification | Agent, Tooth Bonding, 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 | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-22 |
| Decision Date | 2008-10-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10386040008495 | K082768 | 000 |
| D0470042201 | K082768 | 000 |
| D0470119421 | K082768 | 000 |
| D0470119471 | K082768 | 000 |
| 14548161282628 | K082768 | 000 |
| 14548161282826 | K082768 | 000 |
| 14548161296489 | K082768 | 000 |
| 14548161296526 | K082768 | 000 |
| 04548161331459 | K082768 | 000 |
| D0470042171 | K082768 | 000 |