Southern Implants PEEK Abutments

Abutment, Implant, Dental, Endosseous

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 Peek Abutments.

Pre-market Notification Details

Device IDK172160
510k NumberK172160
Device Name:Southern Implants PEEK Abutments
ClassificationAbutment, Implant, Dental, Endosseous
Applicant Southern Implants (Pty) Ltd 1 Albert Street Irene,  ZA 0062
ContactLauranda Breytenbach
CorrespondentKevin Walls
Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton,  CO  80127
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-18
Decision Date2018-02-09
Summary:summary

NIH GUDID Devices

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