TheraCem
Cement, Dental
BISCO, INC.
The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Theracem.
Pre-market Notification Details
| Device ID | K161256 |
| 510k Number | K161256 |
| Device Name: | TheraCem |
| Classification | Cement, Dental |
| 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 | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-04 |
| Decision Date | 2016-07-29 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D757D46502S0 | K161256 | 000 |
| 00810111541305 | K161256 | 000 |
| 00810111541282 | K161256 | 000 |
| 00810111541268 | K161256 | 000 |
| 00810111541275 | K161256 | 000 |
| D757D463110 | K161256 | 000 |
| D757D465010 | K161256 | 000 |
| D757D46311P1 | K161256 | 000 |
| D757D46302PS0 | K161256 | 000 |
| D757D46302S0 | K161256 | 000 |
| 00810111541299 | K161256 | 000 |
Trademark Results [TheraCem]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THERACEM 86354297 5171918 Live/Registered |
Bisco Inc. 2014-07-31 |
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