EK Implants And Abutments System

Implant, Endosseous, Root-form

Hiossen, Inc.

The following data is part of a premarket notification filed by Hiossen, Inc. with the FDA for Ek Implants And Abutments System.

Pre-market Notification Details

Device IDK203360
510k NumberK203360
Device Name:EK Implants And Abutments 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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-16
Decision Date2022-01-07

NIH GUDID Devices

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