Piccolo Implants And Accessories

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 Piccolo Implants And Accessories.

Pre-market Notification Details

Device IDK173706
510k NumberK173706
Device Name:Piccolo Implants And Accessories
ClassificationImplant, Endosseous, Root-form
Applicant Southern Implants (Pty) Ltd. 1 Albert Road Irene,  ZA 0062
ContactLauranda Breytenbach
CorrespondentLauranda 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 Received2017-12-04
Decision Date2018-06-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06009544027171 K173706 000
06009544019879 K173706 000
06009544007548 K173706 000
06009544007418 K173706 000
06009544000907 K173706 000
06009544000891 K173706 000
06009544000884 K173706 000
06009544000877 K173706 000
06009544022862 K173706 000
06009544038481 K173706 000
06009544038474 K173706 000
06009544038467 K173706 000
06009544038450 K173706 000
06009544038436 K173706 000
06009544038429 K173706 000
06009544038412 K173706 000
06009544043553 K173706 000
06009544020561 K173706 000
06009544020578 K173706 000
06009544027164 K173706 000
06009544027157 K173706 000
06009544026679 K173706 000
06009544026662 K173706 000
06009544026655 K173706 000
06009544026648 K173706 000
06009544026631 K173706 000
06009544022435 K173706 000
06009544022428 K173706 000
06009544022411 K173706 000
06009544022404 K173706 000
06009544022398 K173706 000
06009544022381 K173706 000
06009544022022 K173706 000
06009544022015 K173706 000
06009544020585 K173706 000
06009544043348 K173706 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.