AMERICAN DENTAL PRODUCTS WETTING AGENT & DESENSITIZER

Agent, Tooth Bonding, Resin

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 Wetting Agent & Desensitizer.

Pre-market Notification Details

Device IDK954133
510k NumberK954133
Device Name:AMERICAN DENTAL PRODUCTS WETTING AGENT & DESENSITIZER
ClassificationAgent, Tooth Bonding, Resin
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 CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-09-01
Decision Date1995-10-30

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