Suglue 3

Cement, Dental

3M Deutschland GMBH

The following data is part of a premarket notification filed by 3m Deutschland Gmbh with the FDA for Suglue 3.

Pre-market Notification Details

Device IDK192992
501k NumberK192992
Device Name:Suglue 3
ClassificationCement, Dental
Applicant 3M Deutschland GMBH ESPE Platz, Seefeld Bavaria,  DE 82229
ContactDesi W. Soegiarto
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
501k Review PanelDental
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2019-10-25
Decision Date2019-11-05

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