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 |