The following data is part of a premarket notification filed by Vivadent (usa), Inc. with the FDA for Heliosit.
Device ID | K802683 |
510k Number | K802683 |
Device Name: | HELIOSIT |
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 | 1980-10-28 |
Decision Date | 1980-11-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() HELIOSIT 73514460 1407310 Live/Registered |
ETABLISSEMENT VIVADENT 1984-12-19 |