INFILTRATION KIT

Sealant, Pit And Fissure, And Conditioner

DMG USA, INC.

The following data is part of a premarket notification filed by Dmg Usa, Inc. with the FDA for Infiltration Kit.

Pre-market Notification Details

Device IDK100062
510k NumberK100062
Device Name:INFILTRATION KIT
ClassificationSealant, Pit And Fissure, And Conditioner
Applicant DMG USA, INC. 23 FRANK MOSSBERG DRIVE Attleboro,  MA  02703
ContactPamela Papineau
CorrespondentPamela Papineau
DMG USA, INC. 23 FRANK MOSSBERG DRIVE Attleboro,  MA  02703
Product CodeEBC  
CFR Regulation Number872.3765 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-01-11
Decision Date2010-03-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
EDMG2204031 K100062 000
EDMG2204021 K100062 000
EDMG2204011 K100062 000
EDMG2204000 K100062 000
EDMG2203850 K100062 000

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