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 |