The following data is part of a premarket notification filed by Daville Materials Llc with the FDA for Dmrc Light Cure Orthodontic Adhesive System.
| Device ID | K142880 |
| 510k Number | K142880 |
| Device Name: | DMRC Light Cure Orthodontic Adhesive System |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | Daville Materials LLC 3420 Fostoria Way Suite A-200 San Ramon, CA 94583 |
| Contact | Dong Hua |
| Correspondent | Dong Hua Daville Materials LLC 3420 Fostoria Way Suite A-200 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 | 2015-02-04 |