Southern Implants MAX 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 Southern Implants Max Implant System.

Pre-market Notification Details

Device IDK191054
510k NumberK191054
Device Name:Southern Implants MAX Implant 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 Received2019-04-19
Decision Date2019-12-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06009544037002 K191054 000
06009544037026 K191054 000
06009544037170 K191054 000
06009544036913 K191054 000
06009544036920 K191054 000
06009544036937 K191054 000
06009544036944 K191054 000
06009544036951 K191054 000
06009544036968 K191054 000
06009544036982 K191054 000
06009544036999 K191054 000
06009544037019 K191054 000

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