ZENITH 40% PHOSPHORIC ACID GEL

Sealant, Pit And Fissure, And Conditioner

FOREMOST DENTAL MFG., INC.

The following data is part of a premarket notification filed by Foremost Dental Mfg., Inc. with the FDA for Zenith 40% Phosphoric Acid Gel.

Pre-market Notification Details

Device IDK890464
510k NumberK890464
Device Name:ZENITH 40% PHOSPHORIC ACID GEL
ClassificationSealant, Pit And Fissure, And Conditioner
Applicant FOREMOST DENTAL MFG., INC. 242 SOUTH DEAN ST. Englewood,  NJ  07631
ContactTim Wolf
CorrespondentTim Wolf
FOREMOST DENTAL MFG., INC. 242 SOUTH DEAN ST. Englewood,  NJ  07631
Product CodeEBC  
CFR Regulation Number872.3765 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-01-30
Decision Date1989-02-13

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