TheraCal DC
Liner, Cavity, Calcium Hydroxide
Bisco, Inc.
The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Theracal Dc.
Pre-market Notification Details
| Device ID | K180344 |
| 510k Number | K180344 |
| Device Name: | TheraCal DC |
| Classification | Liner, Cavity, Calcium Hydroxide |
| Applicant | Bisco, Inc. 1100 West Irving Park Road Schaumburg, IL 60193 |
| Contact | Ryan Hobson |
| Correspondent | Ryan Hobson Bisco, Inc. 1100 West Irving Park Road Schaumburg, IL 60193 |
| Product Code | EJK |
| CFR Regulation Number | 872.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-08 |
| Decision Date | 2018-04-05 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D757H34110P1 | K180344 | 000 |
| D757H340100 | K180344 | 000 |
| 00810111540797 | K180344 | 000 |
| 00810111540803 | K180344 | 000 |
| 00810111542944 | K180344 | 000 |
| 00810111542937 | K180344 | 000 |
Trademark Results [TheraCal DC]
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 |
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