The following data is part of a premarket notification filed by Den-mat Holdings, Llc with the FDA for Nuance Universal.
| Device ID | K162967 |
| 510k Number | K162967 |
| Device Name: | Nuance UNIVERSAL |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Den-Mat Holdings, LLC 1017 W. Central Avenue Lompoc, CA 93436 |
| Contact | Helen Ragus |
| Correspondent | Helen Ragus Den-Mat Holdings, LLC 1017 W. Central Avenue Lompoc, CA 93436 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-24 |
| Decision Date | 2017-03-24 |
| Summary: | summary |