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 IDK182917
510k NumberK182917
Device Name:FluoroCal
ClassificationVarnish, Cavity
Applicant Bisco, Inc 1100 W Irving Park Rd Schaumburg,  IL  60193
ContactRyan Hobson
CorrespondentRyan Hobson
Bisco, Inc 1100 W Irving Park Rd Schaumburg,  IL  60193
Product CodeLBH  
CFR Regulation Number872.3260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-19
Decision Date2019-11-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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
FLUOROCAL
88721166 not registered Live/Pending
Bisco Inc.
2019-12-10
FLUOROCAL
FLUOROCAL
87094228 not registered Live/Pending
Bisco, Inc.
2016-07-06
FLUOROCAL
FLUOROCAL
75755818 2545718 Live/Registered
Acton Technologies, Inc.
1999-07-20

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