EM SA Implant System

Implant, Endosseous, Root-form

Hiossen, Inc.

The following data is part of a premarket notification filed by Hiossen, Inc. with the FDA for Em Sa Implant System.

Pre-market Notification Details

Device IDK191201
501k NumberK191201
Device Name:EM SA Implant System
ClassificationImplant, Endosseous, Root-form
Applicant Hiossen, Inc. 85 Ben Fairless Drive Fairless Hills,  PA  19030
ContactPeter Lee
CorrespondentPeter Lee
Hiossen, Inc. 85 Ben Fairless Drive Fairless Hills,  PA  19030
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
501k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-06
Decision Date2019-11-15

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