AMERICAN DENTAL PRODUCTS ETCH-DETECT

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 Etch-detect.

Pre-market Notification Details

Device IDK991099
510k NumberK991099
Device Name:AMERICAN DENTAL PRODUCTS ETCH-DETECT
ClassificationSealant, Pit And Fissure, And Conditioner
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 CodeEBC  
CFR Regulation Number872.3765 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-04-01
Decision Date1999-06-10
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.