TheraBase, TheraBase Ca

Cement, Dental

Bisco, Inc.

The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Therabase, Therabase Ca.

Pre-market Notification Details

Device IDK192007
510k NumberK192007
Device Name:TheraBase, TheraBase Ca
ClassificationCement, Dental
Applicant Bisco, Inc. 1100 West Irving Park Rd. Schaumburg,  IL  60193
ContactDiana Vu
CorrespondentDiana Vu
Bisco, Inc. 1100 West Irving Park Rd. Schaumburg,  IL  60193
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
510k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-29
Decision Date2020-03-17

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