The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Msn-006.
| Device ID | K141562 |
| 510k Number | K141562 |
| Device Name: | MSN-006 |
| Classification | Crown And Bridge, Temporary, 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 | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-12 |
| Decision Date | 2014-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D0470094012 | K141562 | 000 |
| 24548161316917 | K141562 | 000 |
| 24548161316900 | K141562 | 000 |
| 24548161316894 | K141562 | 000 |
| 24548161316887 | K141562 | 000 |
| 24548161316870 | K141562 | 000 |
| 24548161316863 | K141562 | 000 |
| 24548161316856 | K141562 | 000 |
| 24548161316849 | K141562 | 000 |
| 24548161316924 | K141562 | 000 |
| 00386040012495 | K141562 | 000 |
| D0470093922 | K141562 | 000 |
| D0470094002 | K141562 | 000 |
| D0470093992 | K141562 | 000 |
| D0470093982 | K141562 | 000 |
| D0470093972 | K141562 | 000 |
| D0470093962 | K141562 | 000 |
| D0470093952 | K141562 | 000 |
| D0470093942 | K141562 | 000 |
| D0470093932 | K141562 | 000 |
| 24548161316825 | K141562 | 000 |