The following data is part of a premarket notification filed by Danville Materials, Inc. with the FDA for Dmrc Nanoflow Dmrc Nanocomposite Ebond Sure Etch Gel Sure Etch Liquid.
| Device ID | K121880 |
| 510k Number | K121880 |
| Device Name: | DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID |
| Classification | Material, Tooth Shade, Resin |
| Applicant | DANVILLE MATERIALS, INC. 3420 Fostoria Way Ste A200 San Ramon, CA 94583 |
| Contact | Lindsay Tilton |
| Correspondent | Lindsay Tilton DANVILLE MATERIALS, INC. 3420 Fostoria Way Ste A200 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 | 2012-06-28 |
| Decision Date | 2012-09-25 |