The following data is part of a premarket notification filed by Heraeus Kulzer Gmbh with the FDA for Neun.
| Device ID | K073554 |
| 510k Number | K073554 |
| Device Name: | NEUN |
| Classification | Material, Tooth Shade, Resin |
| Applicant | HERAEUS KULZER GMBH 4315 SOUTH LAFAYETTE BLVD. South Bend, IN 46614 -2517 |
| Contact | Cheryl V Zimmerman |
| Correspondent | Cheryl V Zimmerman HERAEUS KULZER GMBH 4315 SOUTH LAFAYETTE BLVD. South Bend, IN 46614 -2517 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-18 |
| Decision Date | 2008-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J014660354710 | K073554 | 000 |
| J014660354920 | K073554 | 000 |
| J014660354930 | K073554 | 000 |
| J014660390080 | K073554 | 000 |
| J014660390090 | K073554 | 000 |
| J014660390100 | K073554 | 000 |
| J014660390110 | K073554 | 000 |
| J014660390120 | K073554 | 000 |
| J014660390130 | K073554 | 000 |
| J014660390140 | K073554 | 000 |
| J014660390150 | K073554 | 000 |
| J014660390160 | K073554 | 000 |
| J014660390170 | K073554 | 000 |
| J014660390180 | K073554 | 000 |
| J014660390190 | K073554 | 000 |
| J014660390200 | K073554 | 000 |
| J014660354910 | K073554 | 000 |
| J014660354900 | K073554 | 000 |
| J014660354720 | K073554 | 000 |
| J014660354730 | K073554 | 000 |
| J014660354740 | K073554 | 000 |
| J014660354750 | K073554 | 000 |
| J014660354760 | K073554 | 000 |
| J014660354770 | K073554 | 000 |
| J014660354780 | K073554 | 000 |
| J014660354790 | K073554 | 000 |
| J014660354800 | K073554 | 000 |
| J014660354810 | K073554 | 000 |
| J014660354820 | K073554 | 000 |
| J014660354830 | K073554 | 000 |
| J014660354870 | K073554 | 000 |
| J014660354880 | K073554 | 000 |
| J014660354890 | K073554 | 000 |
| J014660390240 | K073554 | 000 |
| J014660390250 | K073554 | 000 |
| J014660390260 | K073554 | 000 |
| J014660354860 | K073554 | 000 |
| J014660390210 | K073554 | 000 |
| J014660390220 | K073554 | 000 |
| J014660390230 | K073554 | 000 |
| J014660982750 | K073554 | 000 |
| J014660982770 | K073554 | 000 |
| J014660982600 | K073554 | 000 |
| J014660982610 | K073554 | 000 |
| J014660982640 | K073554 | 000 |
| J014660982650 | K073554 | 000 |
| J014660818381 | K073554 | 000 |
| J014660818391 | K073554 | 000 |
| J014660818420 | K073554 | 000 |
| J014660818430 | K073554 | 000 |
| J014660818480 | K073554 | 000 |
| J014660354850 | K073554 | 000 |
| J014660354840 | K073554 | 000 |
| J014660390270 | K073554 | 000 |
| J014660390280 | K073554 | 000 |
| J014660390290 | K073554 | 000 |
| J014660390300 | K073554 | 000 |
| J014660467310 | K073554 | 000 |
| J014660467320 | K073554 | 000 |
| J014660467330 | K073554 | 000 |
| J014660467340 | K073554 | 000 |
| J014660467350 | K073554 | 000 |
| J014660467360 | K073554 | 000 |
| J014660467370 | K073554 | 000 |
| J014660467380 | K073554 | 000 |
| J014660554750 | K073554 | 000 |
| J014660554760 | K073554 | 000 |
| J014660641910 | K073554 | 000 |
| J014660818490 | K073554 | 000 |