Ecosite Bulk Fill

Material, Tooth Shade, Resin

DMG USA Inc.

The following data is part of a premarket notification filed by Dmg Usa Inc. with the FDA for Ecosite Bulk Fill.

Pre-market Notification Details

Device IDK171772
510k NumberK171772
Device Name:Ecosite Bulk Fill
ClassificationMaterial, Tooth Shade, Resin
Applicant DMG USA Inc. 23 Frank Mossberg Drive Attleboro,  MA  02703
ContactGordon Craig
CorrespondentPam Papineau
Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer,  MA  01432
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-14
Decision Date2018-01-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
EDMG2207571 K171772 000
EDMG2229020 K171772 000
EDMG2229001 K171772 000
EDMG2207501 K171772 000
EDMG2207511 K171772 000
EDMG2207521 K171772 000
EDMG2207531 K171772 000
EDMG2207541 K171772 000
EDMG2207551 K171772 000
EDMG2207561 K171772 000
EDMG2229010 K171772 000

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