TempoCem Clear

Cement, Dental

DMG USA, INC.

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

Pre-market Notification Details

Device IDK160443
510k NumberK160443
Device Name:TempoCem Clear
ClassificationCement, Dental
Applicant DMG USA, INC. 23 FRANK MOSSBERG DRIVE Attleboro,  MA  02703
ContactGordon Craig
CorrespondentPam Papineau
DELPHI MEDICAL DEVICE CONSULTING, INC. 5 WHITCOMB AVE Ayer,  MA  01432
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-17
Decision Date2016-09-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
EDMG2132008 K160443 000

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