The following data is part of a premarket notification filed by Vivadent (usa), Inc. with the FDA for Colorant.
Device ID | K790438 |
510k Number | K790438 |
Device Name: | COLORANT |
Classification | Coating, Filling Material, Resin |
Applicant | VIVADENT (USA), INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EBD |
CFR Regulation Number | 872.3310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-03-07 |
Decision Date | 1979-04-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() COLORANT 86000076 4478191 Live/Registered |
Tay, Sonia 2013-07-01 |