The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for G-premio Bond.
| Device ID | K143140 |
| 510k Number | K143140 |
| Device Name: | G-Premio BOND |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Contact | Dr. Mark Heiss |
| Correspondent | Dr. 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 | 2014-11-03 |
| Decision Date | 2015-04-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04548161327575 | K143140 | 000 |
| 14548161321952 | K143140 | 000 |
| 14548161321945 | K143140 | 000 |
| D0470126961 | K143140 | 000 |
| D0470126911 | K143140 | 000 |