The following data is part of a premarket notification filed by Vivadent (usa), Inc. with the FDA for Heliobond.
| Device ID | K802681 |
| 510k Number | K802681 |
| Device Name: | HELIOBOND |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | VIVADENT (USA), INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| 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 |
|---|---|
![]() HELIOBOND 77571116 3807777 Live/Registered |
ROYAL ADHESIVES AND SEALANTS, LLC 2008-09-16 |
![]() HELIOBOND 75099998 2101021 Live/Registered |
IVOCLAR VIVADENT, INC. 1996-05-07 |