The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Mfp-051.
| Device ID | K123631 |
| 510k Number | K123631 |
| Device Name: | MFP-051 |
| Classification | Material, Tooth Shade, 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 | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-23 |
| Decision Date | 2013-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04548161327568 | K123631 | 000 |
| 14548161327381 | K123631 | 000 |
| 14548161327374 | K123631 | 000 |
| 14548161327367 | K123631 | 000 |
| 14548161327350 | K123631 | 000 |
| 14548161327343 | K123631 | 000 |
| 14548161327336 | K123631 | 000 |
| 14548161327329 | K123631 | 000 |
| 14548161327312 | K123631 | 000 |
| 14548161327305 | K123631 | 000 |
| 14548161327299 | K123631 | 000 |
| 14548161327282 | K123631 | 000 |
| 14548161327275 | K123631 | 000 |
| 14548161327268 | K123631 | 000 |
| 14548161327251 | K123631 | 000 |
| 14548161327244 | K123631 | 000 |
| 14548161327398 | K123631 | 000 |
| 04548161327407 | K123631 | 000 |
| 04548161327551 | K123631 | 000 |
| 04548161327544 | K123631 | 000 |
| 04548161327537 | K123631 | 000 |
| 04548161327520 | K123631 | 000 |
| 04548161327513 | K123631 | 000 |
| 04548161327506 | K123631 | 000 |
| 04548161327490 | K123631 | 000 |
| 04548161327483 | K123631 | 000 |
| 04548161327476 | K123631 | 000 |
| 04548161327469 | K123631 | 000 |
| 04548161327452 | K123631 | 000 |
| 04548161327445 | K123631 | 000 |
| 04548161327438 | K123631 | 000 |
| 04548161327421 | K123631 | 000 |
| 04548161327414 | K123631 | 000 |
| 14548161327237 | K123631 | 000 |