StoneBite And StoneBite Scan

Material, Impression

Dreve Dentamid GmbH

The following data is part of a premarket notification filed by Dreve Dentamid Gmbh with the FDA for Stonebite And Stonebite Scan.

Pre-market Notification Details

Device IDK190571
501k NumberK190571
Device Name:StoneBite And StoneBite Scan
ClassificationMaterial, Impression
Applicant Dreve Dentamid GmbH Max-Planck-Strasse 31 Unna,  DE 59423
ContactReiner Altmann
CorrespondentNevine Erian
BQC Consulting LLC 24341 Barbados Dr. Dana Point,  CA  92629
Product CodeELW  
CFR Regulation Number872.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
501k Review PanelDental
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-06
Decision Date2019-11-07

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