HELIOSIT
Material, Tooth Shade, Resin
VIVADENT (USA), INC.
The following data is part of a premarket notification filed by Vivadent (usa), Inc. with the FDA for Heliosit.
Pre-market Notification Details
| 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 |
Trademark Results [HELIOSIT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HELIOSIT 73514460 1407310 Live/Registered |
ETABLISSEMENT VIVADENT 1984-12-19 |
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