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 |
J014660390230 | K073554 | 000 |
J014660390220 | K073554 | 000 |
J014660390210 | K073554 | 000 |
J014660354860 | K073554 | 000 |
J014660354850 | K073554 | 000 |
J014660354840 | K073554 | 000 |
J014660641910 | K073554 | 000 |
J014660554760 | K073554 | 000 |
J014660982750 | K073554 | 000 |
J014660982770 | K073554 | 000 |
J014660982600 | K073554 | 000 |
J014660818480 | K073554 | 000 |
J014660818430 | K073554 | 000 |
J014660818420 | K073554 | 000 |
J014660818391 | K073554 | 000 |
J014660818381 | K073554 | 000 |
J014660982650 | K073554 | 000 |
J014660982640 | K073554 | 000 |
J014660982610 | K073554 | 000 |
J014660554750 | K073554 | 000 |