PrimeTaper EV Dental Implants Ø3.0, DS Implants Abutments With EV Connection (XS)

Implant, Endosseous, Root-form

Dentsply Sirona

The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Primetaper Ev Dental Implants Ø3.0, Ds Implants Abutments With Ev Connection (xs).

Pre-market Notification Details

Device IDK220841
510k NumberK220841
Device Name:PrimeTaper EV Dental Implants Ø3.0, DS Implants Abutments With EV Connection (XS)
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 Received2022-03-23
Decision Date2022-11-16

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