HELIOSEAL
Sealant, Pit And Fissure, And Conditioner
VIVADENT (USA), INC.
The following data is part of a premarket notification filed by Vivadent (usa), Inc. with the FDA for Helioseal.
Pre-market Notification Details
| Device ID | K813015 |
| 510k Number | K813015 |
| Device Name: | HELIOSEAL |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | VIVADENT (USA), INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-27 |
| Decision Date | 1981-12-02 |
Trademark Results [HELIOSEAL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HELIOSEAL 86177500 4706510 Live/Registered |
HGST NETHERLANDS B.V. 2014-01-28 |
 HELIOSEAL 77506836 3726279 Live/Registered |
ROYAL ADHESIVES AND SEALANTS, LLC 2008-06-24 |
 HELIOSEAL 73630576 1474715 Live/Registered |
VIVADENT (USA), INC. 1986-11-17 |
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