AMADEO, M-UK1015 (incl. Attachments And Accessories)

Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece

W&H Dentalwerk Buermoss GmbH

The following data is part of a premarket notification filed by W&h Dentalwerk Buermoss Gmbh with the FDA for Amadeo, M-uk1015 (incl. Attachments And Accessories).

Pre-market Notification Details

Device IDK213221
510k NumberK213221
Device Name:AMADEO, M-UK1015 (incl. Attachments And Accessories)
ClassificationDrill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Applicant W&H Dentalwerk Buermoss GmbH Ignaz-Glaser-Strasse 53 Buermoos,  AT 5111
ContactWeidler Gerhard
CorrespondentWeidler Gerhard
W&H Dentalwerk Buermoss GmbH Ignaz-Glaser-Strasse 53 Buermoos,  AT 5111
Product CodeERL  
CFR Regulation Number874.4250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-29
Decision Date2022-05-26

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