SIMPLANT 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 Guide.

Pre-market Notification Details

Device IDK170849
510k NumberK170849
Device Name:SIMPLANT Guide
ClassificationAccessories, Implant, Dental, Endosseous
Applicant Dentsply Sirona 221 West Philadelphia Street Suite 60W York,  PA  17401
ContactHelen Lewis
CorrespondentHelen Lewis
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 Received2017-03-22
Decision Date2017-06-15
Summary:summary

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