The following data is part of a premarket notification filed by Vivadent (usa), Inc. with the FDA for Heliomat.
| Device ID | K802684 |
| 510k Number | K802684 |
| Device Name: | HELIOMAT |
| Classification | Light, Fiber Optic, Dental |
| Applicant | VIVADENT (USA), INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EAY |
| CFR Regulation Number | 872.4620 [🔎] |
| 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 |
|---|---|
![]() HELIOMAT 73514413 1407560 Dead/Cancelled |
ETABLISSEMENT VIVADENT 1984-12-19 |