Venus Bulk Flow ONE

Material, Tooth Shade, Resin

Kulzer, LLC

The following data is part of a premarket notification filed by Kulzer, Llc with the FDA for Venus Bulk Flow One.

Pre-market Notification Details

Device IDK220605
510k NumberK220605
Device Name:Venus Bulk Flow ONE
ClassificationMaterial, Tooth Shade, Resin
Applicant Kulzer, LLC 4315 S. Lafayette Blvd South Bend,  IN  46614
ContactMarc Henn
CorrespondentMarc Henn
Kulzer, LLC 4315 S. Lafayette Blvd South Bend,  IN  46614
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-02
Decision Date2022-04-21

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