Simplant Digital Guide

Accessories, Implant, Dental, Endosseous

Dentsply Sirona

The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Simplant Digital Guide.

Pre-market Notification Details

Device IDK193405
510k NumberK193405
Device Name:Simplant Digital Guide
ClassificationAccessories, Implant, Dental, Endosseous
Applicant Dentsply Sirona 221 West Philadelphia Street, Suite 60W York,  PA  17401
ContactKarl Nittinger
CorrespondentKarl Nittinger
Dentsply Sirona 221 West Philadelphia Street, Suite 60W York,  PA  17401
Product CodeNDP  
CFR Regulation Number872.3980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-09
Decision Date2020-09-02

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