The following data is part of a premarket notification filed by Coltene/whaledent Inc. with the FDA for Coltene Aura Compomer Restorative System.
| Device ID | K003034 |
| 510k Number | K003034 |
| Device Name: | COLTENE AURA COMPOMER RESTORATIVE SYSTEM |
| Classification | Material, Tooth Shade, Resin |
| Applicant | COLTENE/WHALEDENT INC. 750 CORPORATE DR. Mahwah, NJ 07430 -2009 |
| Contact | H. J Vogelstein |
| Correspondent | H. J Vogelstein COLTENE/WHALEDENT INC. 750 CORPORATE DR. Mahwah, NJ 07430 -2009 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-28 |
| Decision Date | 2000-11-30 |