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 IDK222497
510k NumberK222497
Device Name:Zaga Zygomatic System
ClassificationImplant, Endosseous, Root-form
Applicant Southern Implants (Pty) Ltd 1 Albert Road Irene,  ZA 0062
ContactLeith C. Cumming
CorrespondentLeith C. Cumming
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 Received2022-08-18
Decision Date2022-11-09

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