The following data is part of a premarket notification filed by Dentaurum with the FDA for Dentaurum Mix Two-paste Bracket Adhesive.
| Device ID | K030977 |
| 510k Number | K030977 |
| Device Name: | DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | DENTAURUM 10 PHEASANT RUN Newtown, PA 18940 |
| Contact | Jan W.a. Doorschodt |
| Correspondent | Jan W.a. Doorschodt DENTAURUM 10 PHEASANT RUN Newtown, PA 18940 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-28 |
| Decision Date | 2003-08-25 |