OmniTaper EV Dental Implants, DS Implants Abutments With EV Connection

Implant, Endosseous, Root-form

Dentsply Sirona

The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Omnitaper Ev Dental Implants, Ds Implants Abutments With Ev Connection.

Pre-market Notification Details

Device IDK221094
510k NumberK221094
Device Name:OmniTaper EV Dental Implants, DS Implants Abutments With EV Connection
ClassificationImplant, Endosseous, Root-form
Applicant Dentsply Sirona 221 West Philadelphia Street, Suite 60W York,  PA  17401
ContactCourtney Clark
CorrespondentCourtney Clark
Dentsply Sirona 221 West Philadelphia Street, Suite 60W York,  PA  17401
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-14
Decision Date2022-11-16

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