ScanX Edge

System, X-ray, Extraoral Source, Digital

Dürr Dental SE

The following data is part of a premarket notification filed by Dürr Dental Se with the FDA for Scanx Edge.

Pre-market Notification Details

Device IDK202633
510k NumberK202633
Device Name:ScanX Edge
ClassificationSystem, X-ray, Extraoral Source, Digital
Applicant Dürr Dental SE Höpfigheimer Str. 17 Bietigheim-bissingen,  DE 74321
ContactOliver Lange
CorrespondentDaniel Kamm
Kamm & Associates 8870 Ravello Ct Naples,  FL  34114
Product CodeMUH  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-11
Decision Date2020-10-07

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