Nano Varnish, Plaquit, Lightpaint On Surface

Coating, Filling Material, Resin

DREVE DENTAMID GMBH

The following data is part of a premarket notification filed by Dreve Dentamid Gmbh with the FDA for Nano Varnish, Plaquit, Lightpaint On Surface.

Pre-market Notification Details

Device IDK162408
510k NumberK162408
Device Name:Nano Varnish, Plaquit, Lightpaint On Surface
ClassificationCoating, Filling Material, Resin
Applicant DREVE DENTAMID GMBH MAX-PLANCK-STRASSE 31 Unna,  DE 59423
ContactReiner Altmann
CorrespondentReiner Altmann
DREVE DENTAMID GMBH MAX-PLANCK-STRASSE 31 Unna,  DE 59423
Product CodeEBD  
CFR Regulation Number872.3310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-08-29
Decision Date2018-04-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
E239D389001 K162408 000
E239D382391 K162408 000
E239D381241 K162408 000
E239D381231 K162408 000
E239D38900US1 K162408 000
E239D38124US1 K162408 000
E239D38123US1 K162408 000

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