The following data is part of a premarket notification filed by Ormco Corp. with the FDA for Thermaset.
Device ID | K946255 |
510k Number | K946255 |
Device Name: | THERMASET |
Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
Applicant | ORMCO CORP. 1332 SOUTH LONE HILL AVE. Glendora, CA 91740 |
Contact | Jeffrey A Anderson |
Correspondent | Jeffrey A Anderson ORMCO CORP. 1332 SOUTH LONE HILL AVE. Glendora, CA 91740 |
Product Code | DYH |
CFR Regulation Number | 872.3750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-12-22 |
Decision Date | 1995-01-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
THERMASET 77877670 3810790 Live/Registered |
GRAHAM PACKAGING PET TECHNOLOGIES, INC. 2009-11-20 |