Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003394627

FEI Number

3003394627

Entity Name

SOUTHERN IMPLANTS (PTY) LTD

City/State/Country

IRENE Gauteng, ZA

Establishment Address

ONE ALBERT ROAD, IRENE Gauteng 0062, ZA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SOUTHERN IMPLANTS (PTY) LTD (Owner Number: 9073913)

Owner / Operator Contact Address

ONE ALBERT ROAD, --, IRENE, GAUTENG, ZA-NOTA 0062, ZA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K232726

PMA Number

N/A

All Registered Proprietary Names

Co-Axis Implants Implant, Endosseous, Root-Form - NSI hexed and Non hexed External Prosthetic Cap Piccolo Implants Piccolo Abutments screwdrivers, Dental, Intraoral Placement and removal tools, Dental, Intraoral laboratory pieces used for fabrication of dental prosthetics Drill, Tools and Accessories, Dental, Intraoral ZAGA Zygomatic System Provata Co-Axis Implants Provata Abutments Provata Implants Provata PEEK Abutments Piccolo PEEK Abutments TIB Abutments Implant, Endosseous, Root-Form - 12 Deg Co-Axis Tapered Implants Implant, Endosseous, Root-Form - Parrallel Implants External hex implants External Hex Co-Axis Implants 12 degrees External Hex Co-Axis Implants 24 degrees MSC implants External hex passive abutments External hex cosmetic abutments External hex gold abutments abutments External hex titanium abutments External hex compact conicals abutments External hex cobalt chrome abutments External hex anatomical abutments Inversa Implants Inverta Implant Implant, Endosseous, Root-Form - Zygomatic Implants Implant, Endosseous, Root-Form - Internal Oct Parrallel Implants, Internal Oct Tapered Implant Instrument trays Implant, Endosseous, Root-Form - Int Oct Parrallel Implant, Internal Oct Tapered Implant PEEK Abutments Single Platform SP1 Implant System and accessories TIB Abutment System Implant, Endosseous, Root-Form - Max Implant DC Implants and Accessories Deep Conical Implants and Accessories Implant, Endosseous, Root-Form - Tri-Nex Implant External Hex implant System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2010-12-21
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2010-12-21
NOK	Material, External Aesthetic Restoration, No Adhesive	General, Plastic Surgery	Class 1	878.3800	2023-06-29
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-06-08
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-06-08
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2005-06-08
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2022-11-15
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-09-07
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-09-07
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-12-09
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2020-10-27
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-10-27
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2010-12-21
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2010-12-21
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2017-11-07
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-11-07
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-11-22
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2013-01-30
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2010-12-21
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2022-03-07
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2010-12-21
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2010-12-21
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-02-15
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-12-04
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2023-12-04
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2023-12-04
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-04-22
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2023-04-22
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2010-12-21
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2010-12-21
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2017-07-21
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-07-21
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2010-12-21
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2010-12-21
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2024-04-10

Official Correspondent

No official correspondent registered.

US Agent Details

David Luiz Business: SOUTHERN IMPLANTS NORTH AMERICA Inc. Email: david@southernimplants.com Phone: (561) 4720991

Related Public Records

Same Entity

SOUTHERN IMPLANTS (PTY) LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07
K120793	Z-Systems AG	Z-LOOK3 EVO SLM	2012-12-21
K130140	Intra-Lock International	INTRA-LOCK OP DENTAL IMPLANT	2013-08-01
K925778	Nobelpharma USA, Inc.	BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES	1993-04-14
K903999	O Co., Inc.	OBUTMENT HB	1992-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026	S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil	2	IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	2	Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Z-0029-05	Implant Innovations, Inc.	2	EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003394627. Last updated year: 2026. Please use registration number 3003394627 when referencing this establishment in official correspondence.