The following data is part of a premarket notification filed by Danville Materials, Llc with the FDA for Dmrc Bulk Fill.
| Device ID | K151088 |
| 510k Number | K151088 |
| Device Name: | DMRC Bulk Fill |
| Classification | Material, Tooth Shade, Resin |
| Applicant | DANVILLE MATERIALS, LLC 3420 FOSTORIA WAY SUITE A-200 San Ramon, CA 94583 |
| Contact | Dong Hua |
| Correspondent | Dong Hua DANVILLE MATERIALS, LLC 3420 FOSTORIA WAY SUITE A-200 San Ramon, CA 94583 |
| 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 | 2015-08-28 |