PrimeTaper EV Dental Implant

Implant, Endosseous, Root-form

Dentsply Sirona, Inc.

The following data is part of a premarket notification filed by Dentsply Sirona, Inc. with the FDA for Primetaper Ev Dental Implant.

Pre-market Notification Details

Device IDK210610
510k NumberK210610
Device Name:PrimeTaper EV Dental Implant
ClassificationImplant, Endosseous, Root-form
Applicant Dentsply Sirona, Inc. 221 West Philadelphia Street, Suite 60W York,  PA  17401
ContactKarl J Nittinger
CorrespondentRebecca Sporer
Dentsply Sirona, Inc. 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 Received2021-03-01
Decision Date2021-08-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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07392532258602 K210610 000

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