The following data is part of a premarket notification filed by Danville Materials, Llc. with the FDA for Dmrc Self-cure Bracket Adhesive One Step And Primer.
| Device ID | K142886 |
| 510k Number | K142886 |
| Device Name: | DMRC Self-Cure Bracket Adhesive One Step And Primer |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | DANVILLE MATERIALS, LLC. 3420 Fostoria Way Ste A200 San Ramon, CA 94583 |
| Contact | Dong Hua |
| Correspondent | Dong Hua DANVILLE MATERIALS, LLC. 3420 Fostoria Way Ste A200 San Ramon, CA 94583 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-02 |
| Decision Date | 2015-03-18 |
| Summary: | summary |