THERACAL LC
Liner, Cavity, Calcium Hydroxide
BISCO, INC.
The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Theracal Lc.
Pre-market Notification Details
| Device ID | K063237 |
| 510k Number | K063237 |
| Device Name: | THERACAL LC |
| Classification | Liner, Cavity, Calcium Hydroxide |
| Applicant | BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
| Contact | Benjamin Lichtenwalner |
| Correspondent | Benjamin Lichtenwalner BISCO, INC. 1100 WEST IRVING PARK RD. 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 | 2006-10-26 |
| Decision Date | 2006-12-08 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D757H3302S0 | K063237 | 000 |
| D757H33010 | K063237 | 000 |
| 00810111540001 | K063237 | 000 |
| 00810111540032 | K063237 | 000 |
Trademark Results [THERACAL LC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THERACAL LC 85145428 4154830 Live/Registered |
Bisco, Inc. 2010-10-05 |
 THERACAL LC 77120792 not registered Dead/Abandoned |
Bisco, Inc. 2007-03-02 |
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