BA Pit & Fissure Sealant

Sealant, Pit And Fissure, And Conditioner

Apex Dental Materials, Inc.

The following data is part of a premarket notification filed by Apex Dental Materials, Inc. with the FDA for Ba Pit & Fissure Sealant.

Pre-market Notification Details

Device IDK190998
501k NumberK190998
Device Name:BA Pit & Fissure Sealant
ClassificationSealant, Pit And Fissure, And Conditioner
Applicant Apex Dental Materials, Inc. 330 Telser Road Lake Zurich,  IL  60047
ContactScott Lamerand
CorrespondentScott Lamerand
Apex Dental Materials, Inc. 330 Telser Road Lake Zurich,  IL  60047
Product CodeEBC  
CFR Regulation Number872.3765 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
501k Review PanelDental
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-16
Decision Date2019-11-08

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