ZAGA Zygomatic System

Implant, Endosseous, Root-form

Southern Implants (Pty) Ltd

The following data is part of a premarket notification filed by Southern Implants (pty) Ltd with the FDA for Zaga Zygomatic System.

Pre-market Notification Details

Device IDK192651
510k NumberK192651
Device Name:ZAGA Zygomatic System
ClassificationImplant, Endosseous, Root-form
Applicant Southern Implants (Pty) Ltd 1 Albert Road Irene,  ZA 0062
ContactLauranda G Breytenbach
CorrespondentLauranda G Breytenbach
Southern Implants (Pty) Ltd 1 Albert Road Irene,  ZA 0062
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-24
Decision Date2020-05-07

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