FluoroCal
Varnish, Cavity
Bisco, Inc
The following data is part of a premarket notification filed by Bisco, Inc with the FDA for Fluorocal.
Pre-market Notification Details
| Device ID | K182917 |
| 510k Number | K182917 |
| Device Name: | FluoroCal |
| Classification | Varnish, Cavity |
| Applicant | Bisco, Inc 1100 W Irving Park Rd Schaumburg, IL 60193 |
| Contact | Ryan Hobson |
| Correspondent | Ryan Hobson Bisco, Inc 1100 W Irving Park Rd Schaumburg, IL 60193 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-19 |
| Decision Date | 2019-11-18 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D757B30010 | K182917 | 000 |
| D757B30501K1 | K182917 | 000 |
| D757B3003PS1 | K182917 | 000 |
| 00810111542548 | K182917 | 000 |
| 00810111542890 | K182917 | 000 |
| 00810111542876 | K182917 | 000 |
| 00810111542913 | K182917 | 000 |
| 00810111542906 | K182917 | 000 |
Trademark Results [FluoroCal]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FLUOROCAL 88721166 not registered Live/Pending |
Bisco Inc. 2019-12-10 |
 FLUOROCAL 87094228 not registered Live/Pending |
Bisco, Inc. 2016-07-06 |
 FLUOROCAL 75755818 2545718 Live/Registered |
Acton Technologies, Inc. 1999-07-20 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.