The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Mosaic Universal Composite.
| Device ID | K151094 |
| 510k Number | K151094 |
| Device Name: | Mosaic Universal Composite |
| Classification | Material, Tooth Shade, Resin |
| Applicant | ULTRADENT PRODUCTS, INC. 505 W 10200 S South Jordan, UT 84095 |
| Contact | Karen Kakunes |
| Correspondent | Karen Kakunes ULTRADENT PRODUCTS, INC. 505 W 10200 S South Jordan, UT 84095 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-23 |
| Decision Date | 2015-07-21 |
| Summary: | summary |