MIS Dental Implant System

Implant, Endosseous, Root-form

Dentsply Sirona

The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Mis Dental Implant System.

Pre-market Notification Details

Device IDK200102
510k NumberK200102
Device Name:MIS Dental Implant System
ClassificationImplant, Endosseous, Root-form
Applicant Dentsply Sirona 221 W Philadelphia Street, Suite 60W York,  PA  17401
ContactKarl Nittinger
CorrespondentKarl Nittinger
Dentsply Sirona 221 W Philadelphia Street, Suite 60W York,  PA  17401
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-17
Decision Date2020-09-03

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