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 |