Air-Powered Handpieces And Handpiece Attachments

Handpiece, Air-powered, Dental

W&H DENTALWERK BURMOOS GMBH

The following data is part of a premarket notification filed by W&h Dentalwerk Burmoos Gmbh with the FDA for Air-powered Handpieces And Handpiece Attachments.

Pre-market Notification Details

Device IDK162926
510k NumberK162926
Device Name:Air-Powered Handpieces And Handpiece Attachments
ClassificationHandpiece, Air-powered, Dental
Applicant W&H DENTALWERK BURMOOS GMBH IGNAZ-GLASER-STRABE 53 Bürmoos,  AT 5111
ContactAnja Lindner
CorrespondentAnja Lindner
W&H DENTALWERK BURMOOS GMBH IGNAZ-GLASER-STRABE 53 Bürmoos,  AT 5111
Product CodeEFB  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-10-19
Decision Date2017-02-23
Summary:summary

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