The following data is part of a premarket notification filed by Bisco Inc with the FDA for Theracal Dc.
Device ID | K143292 |
510k Number | K143292 |
Device Name: | TheraCal DC |
Classification | Liner, Cavity, Calcium Hydroxide |
Applicant | Bisco Inc 1100 West Irving Park Road Schaumburg, IL 60193 |
Contact | Michelle Schiltz-taing |
Correspondent | Michelle Schiltz-taing Bisco Inc 1100 West Irving Park Road Schaumburg, IL 60193 |
Product Code | EJK |
CFR Regulation Number | 872.3250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-11-17 |
Decision Date | 2015-08-04 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() THERACAL DC 87927799 not registered Live/Pending |
Bisco Inc. 2018-05-18 |
![]() THERACAL DC 86354283 not registered Dead/Abandoned |
Bisco Inc. 2014-07-31 |
![]() THERACAL DC 85428527 not registered Dead/Abandoned |
Bisco, Inc. 2011-09-21 |