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 |
|---|---|---|
| J014660818490 | K073554 | 000 |
| J014660354850 | 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 |
| J014660354840 | K073554 | 000 |