AMERICAN DENTAL PRODUCTS PIT & FISSUE SEALANT LIGHT CURING

Sealant, Pit And Fissure, And Conditioner

AMERICAN DENTAL PRODUCTS, INC.

The following data is part of a premarket notification filed by American Dental Products, Inc. with the FDA for American Dental Products Pit & Fissue Sealant Light Curing.

Pre-market Notification Details

Device IDK954701
510k NumberK954701
Device Name:AMERICAN DENTAL PRODUCTS PIT & FISSUE SEALANT LIGHT CURING
ClassificationSealant, Pit And Fissure, And Conditioner
Applicant AMERICAN DENTAL PRODUCTS, INC. P.O. BOX 435 Medinah,  IL  60157 -0435
ContactGeorge Nicolae
CorrespondentGeorge Nicolae
AMERICAN DENTAL PRODUCTS, INC. P.O. BOX 435 Medinah,  IL  60157 -0435
Product CodeEBC  
CFR Regulation Number872.3765 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-10-12
Decision Date1995-10-30

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