AMERICAN DENTAL PRODUCTS HG 35 DESENSITIZER WITH FLUORIDE

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 Hg 35 Desensitizer With Fluoride.

Pre-market Notification Details

Device IDK964133
510k NumberK964133
Device Name:AMERICAN DENTAL PRODUCTS HG 35 DESENSITIZER WITH FLUORIDE
ClassificationAgent, Tooth Bonding, Resin
Applicant AMERICAN DENTAL PRODUCTS, INC. 22 W 246 SUNNYSIDE RD. Medinah,  IL  60157 -9705
ContactGeorge Nicolae
CorrespondentGeorge Nicolae
AMERICAN DENTAL PRODUCTS, INC. 22 W 246 SUNNYSIDE RD. Medinah,  IL  60157 -9705
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-10-15
Decision Date1997-01-09

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