DeltaFil, DeltaFil Conditioner

Cement, Dental

DMG Chemisch-Pharmazeutische Fabrik GmbH

The following data is part of a premarket notification filed by Dmg Chemisch-pharmazeutische Fabrik Gmbh with the FDA for Deltafil, Deltafil Conditioner.

Pre-market Notification Details

Device IDK213201
510k NumberK213201
Device Name:DeltaFil, DeltaFil Conditioner
ClassificationCement, Dental
Applicant DMG Chemisch-Pharmazeutische Fabrik GmbH Elbgaustrasse 248 Hamburg,  DE 22547
ContactStephan Schaefer
CorrespondentPamela 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 Received2021-09-29
Decision Date2022-06-01

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