AMERICAN DENTAL PRODUCTS SE BONDEASY

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 Se Bondeasy.

Pre-market Notification Details

Device IDK093014
510k NumberK093014
Device Name:AMERICAN DENTAL PRODUCTS SE BONDEASY
ClassificationAgent, Tooth Bonding, Resin
Applicant AMERICAN DENTAL PRODUCTS, INC. 603-B COUNTRY CLUB DR. Bensenville,  IL  60106 -1329
ContactGeorge Nicolae
CorrespondentGeorge Nicolae
AMERICAN DENTAL PRODUCTS, INC. 603-B COUNTRY CLUB DR. Bensenville,  IL  60106 -1329
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-29
Decision Date2010-04-16
Summary:summary

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