The following data is part of a premarket notification filed by Gc America Inc. with the FDA for Nmf004a.
| Device ID | K173500 |
| 510k Number | K173500 |
| Device Name: | NMF004A |
| Classification | Material, Tooth Shade, Resin |
| Applicant | GC America Inc. 3737 W. 127th Street Alsip, IL 60803 |
| Contact | Mark Heiss |
| Correspondent | Mark Heiss GC America Inc. 3737 W. 127th Street 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 | 2017-11-13 |
| Decision Date | 2018-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D0470123630 | K173500 | 000 |
| 14548161328739 | K173500 | 000 |
| 14548161328722 | K173500 | 000 |
| 04548161328718 | K173500 | 000 |
| 04548161328701 | K173500 | 000 |
| 04548161328695 | K173500 | 000 |
| 04548161328688 | K173500 | 000 |
| 04548161328671 | K173500 | 000 |
| 04548161328664 | K173500 | 000 |
| 04548161328657 | K173500 | 000 |
| 04548161328640 | K173500 | 000 |
| 04548161328633 | K173500 | 000 |
| 04548161328626 | K173500 | 000 |
| 04548161328619 | K173500 | 000 |
| 04548161328602 | K173500 | 000 |
| 04548161337659 | K173500 | 000 |
| D0470123480 | K173500 | 000 |
| D0470123620 | K173500 | 000 |
| D0470123610 | K173500 | 000 |
| D0470123600 | K173500 | 000 |
| D0470123590 | K173500 | 000 |
| D0470123580 | K173500 | 000 |
| D0470123570 | K173500 | 000 |
| D0470123560 | K173500 | 000 |
| D0470123550 | K173500 | 000 |
| D0470123540 | K173500 | 000 |
| D0470123530 | K173500 | 000 |
| D0470123520 | K173500 | 000 |
| D0470123510 | K173500 | 000 |
| D0470123500 | K173500 | 000 |
| D0470123490 | K173500 | 000 |
| 04548161328565 | K173500 | 000 |