The following data is part of a premarket notification filed by Vivadent (usa), Inc. with the FDA for Isoplast.
Device ID | K781787 |
510k Number | K781787 |
Device Name: | ISOPLAST |
Classification | Material, Tooth Shade, Resin |
Applicant | VIVADENT (USA), INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-10-19 |
Decision Date | 1978-12-20 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ISOPLAST 73409948 1312870 Live/Registered |
Upjohn Company; The 1983-01-19 |