Zygomatic Implant 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 Zygomatic Implant System.

Pre-market Notification Details

• Device ID: K173343
• 510k Number: K173343
• Device Name: Zygomatic Implant System
• Classification: Implant, Endosseous, Root-form
• Applicant: Southern Implants (Pty) Ltd 1 Albert Road Irene, ZA 0062
• Contact: Lauranda G. Breytenbach
• Correspondent: Kevin A. Thomas; PaxMed International, LLC 12264 El Camino Real Suite 400 San Diego, CA 92130
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-10-24
• Decision Date: 2018-02-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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