Data / Medical devices / South Africa / Southern Implants (pty) Ltd

Southern Implants (pty) Ltd: FDA-registered device maker in IRENE Gauteng, South Africa, 29 510(k) clearances

Name: Southern Implants (pty) Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Southern Implants (pty) Ltd is registered with the FDA (registration 3003394627) in IRENE Gauteng, South Africa. It lists 7 device types. The FDA files 29 510(k) clearances under its listings, the newest dated April 1, 2024. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3003394627
Address: One Albert Road, IRENE Gauteng, South Africa, 0062
Owner or operator: SOUTHERN IMPLANTS (PTY) LTD (9073913)
Roles: Exporter to the US, Manufacturer
First device listed: June 8, 2005
Registered through: 2027
Brand names listed: Angulated Screw Channel Solution Abutments & SI-BASE Abutments, Co-Axis Implants, DC Implants and Accessories, Deep Conical Implants and Accessories, Drill, Tools and Accessories, Dental, Intraoral, External Hex Co-Axis Implants 12 degrees, External Hex Co-Axis Implants 24 degrees, External Hex implant System and more

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
Dental Abutment Design Software For Dental Laboratory	PNP	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Implant, Endosseous, Root-Form	DZE	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Material, External Aesthetic Restoration, No Adhesive	NOK	1	Manufacturer	accessdata.fda.gov
Prosthesis, Nose, Internal	FZE	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2	Exporter to the US, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 1, 2024	K232726	External Hex Implant System	DZE	Substantially Equivalent	Southern Implants (Pty), Ltd.	accessdata.fda.gov
December 1, 2023	K232418	Single Platform SP1 Implant System	DZE	Substantially Equivalent	Southern Implants (Pty), Ltd.	accessdata.fda.gov
August 1, 2023	K230873	Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments	NHA	Substantially Equivalent	Southern Implants (Pty), Ltd.	accessdata.fda.gov
April 17, 2023	K222469	TIB Abutments	NHA	Substantially Equivalent	Southern Implants (Pty), Ltd.	accessdata.fda.gov
March 6, 2023	K222457	Provata Implant System	DZE	Substantially Equivalent	Southern Implants (Pty), Ltd.	accessdata.fda.gov
November 9, 2022	K222497	Zaga Zygomatic System	DZE	Substantially Equivalent	Southern Implants (Pty), Ltd.	accessdata.fda.gov
March 2, 2022	K210923	Southern Implants Instrument Trays	KCT	Substantially Equivalent	Southern Implants (Pty), Ltd.	accessdata.fda.gov
October 27, 2020	K193084	TIB Abutment System	NHA	Substantially Equivalent	Southern Implants (Pty), Ltd.	accessdata.fda.gov
May 7, 2020	K192651	ZAGA Zygomatic System	DZE	Substantially Equivalent	Southern Implants (Pty), Ltd.	accessdata.fda.gov
December 9, 2019	K191054	Southern Implants MAX Implant System	DZE	Substantially Equivalent	Southern Implants (Pty), Ltd.	accessdata.fda.gov
December 5, 2019	K191250	Southern Implants PEEK Abutments	NHA	Substantially Equivalent	Southern Implants (Pty), Ltd.	accessdata.fda.gov
November 14, 2018	K181850	Inversa Implants	DZE	Substantially Equivalent	Southern Implants (Pty), Ltd.	accessdata.fda.gov
September 6, 2018	K180465	Provata Implant System	DZE	Substantially Equivalent	Southern Implants (Pty), Ltd.	accessdata.fda.gov
June 8, 2018	K173706	Piccolo Implants and Accessories	DZE	Substantially Equivalent	Southern Implants (Pty), Ltd.	accessdata.fda.gov
February 27, 2018	K173343	Zygomatic Implant System	DZE	Substantially Equivalent	Southern Implants (Pty), Ltd.	accessdata.fda.gov
February 9, 2018	K172160	Southern Implants PEEK Abutments	NHA	Substantially Equivalent	Southern Implants (Pty), Ltd.	accessdata.fda.gov
November 6, 2017	K163634	External Hex Implants	DZE	Substantially Equivalent	Southern Implants (Pty), Ltd.	accessdata.fda.gov
June 13, 2017	K163060	Deep Conical (DC) Implants and Accessories	DZE	Substantially Equivalent	Southern Implants (Pty), Ltd.	accessdata.fda.gov
December 1, 2016	K161548	Osseointegrated Fixtures	FZE	Substantially Equivalent	Southern Implants (Pty), Ltd.	accessdata.fda.gov
October 14, 2010	K093562	ENDOSSEOUS DENTAL IMPLANT	DZE	Substantially Equivalent	Southern Implants, Inc.	accessdata.fda.gov
December 22, 2008	K082651	ENDOSSEOUS DENTAL IMPLANT SYSTEM	DZE	Substantially Equivalent	Southern Implants, Inc.	accessdata.fda.gov
November 16, 2007	K071161	ENDOSSEOUS DENTAL IMPLANT SYSTEM	DZE	Substantially Equivalent	Southern Implants, Inc.	accessdata.fda.gov
June 21, 2007	K070841	ENDOSSEOUS DENTAL IMPLANT SYSTEM	DZE	Substantially Equivalent	Southern Implants, Inc.	accessdata.fda.gov
May 24, 2007	K070905	ENDOSSEOUS DENTAL IMPLANT SYSTEM	DZE	Substantially Equivalent	Southern Implants, Inc.	accessdata.fda.gov
June 20, 2006	K061169	ENDOSSEOUS DENTAL IMPLANT	DZE	Substantially Equivalent	Northern Implants, LLC	accessdata.fda.gov
April 5, 2006	K053478	ENDOSSEOUS DENTAL IMPLANT SYSTEM	DZE	Substantially Equivalent	Northern Implants, LLC	accessdata.fda.gov
December 8, 2005	K052490	ENDOSSEOUS DENTAL IMPLANT SYSTEM	DZE	Substantially Equivalent	Northern Implants, LLC	accessdata.fda.gov
May 10, 2002	K020617	NSI HEXED AND NON-HEXED IMPLANT SYSTEM	DZE	Substantially Equivalent	Nsi	accessdata.fda.gov
September 19, 2001	K003620	NSI HEXED AND NON-HEXED IMPLANT SYSTEM	DZE	Substantially Equivalent	Nsi	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
March 8, 2018	79653	Class II	Terminated	SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utiliz	The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.	accessdata.fda.gov

Compare with other makers

Updated April 1, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.