ISODENT

Unit, Operative Dental

EURODENT, INC.

The following data is part of a premarket notification filed by Eurodent, Inc. with the FDA for Isodent.

Pre-market Notification Details

Device IDK894058
510k NumberK894058
Device Name:ISODENT
ClassificationUnit, Operative Dental
Applicant EURODENT, INC. 1381, RUE AMPERE BOUCHERVILLE, QUEBEC Canada J4b 5z5,  CA
ContactAldo Marucchi-foino
CorrespondentAldo Marucchi-foino
EURODENT, INC. 1381, RUE AMPERE BOUCHERVILLE, QUEBEC Canada J4b 5z5,  CA
Product CodeEIA  
CFR Regulation Number872.6640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-06-07
Decision Date1989-12-21

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