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Southern Implants, Inc.

USA · Fairfax

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

7listed device types

Class I 2Class II 5Class III 0

plus 31 registration records and 24 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 3Class II 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

20 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States31 registration records, 24 510(k), 0 PMA, 16 excluded

Brazil4 confirmed, 2 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: SOUTHERN IMPLANTS (PTY) LTD · SOUTHERN IMPLANTS PTY LTD.

FDA 510(k) clearances by year

32007

12008

12010

12016

22017

52018

22019

22020

22022

42023

12024

FDA listed device types

Dental Abutment Design Software For Dental Laboratory 1Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 1Abutment, Implant, Dental, Endosseous 1Prosthesis, Nose, Internal 1Implant, Endosseous, Root-Form 1Material, External Aesthetic Restoration, No Adhesive 1Accessories, Implant, Dental, Endosseous 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K232726	External Hex Implant System	2024-04-01
US	K232418	Single Platform SP1 Implant System	2023-12-01
US	K230873	Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments	2023-08-01
BR	10344420494	INSTRUMENTAIS DE INSERÇÃO EM AÇO INOXIDÁVEL PARA IMPLANTES ZIGOMÁTICOS	Class I
BR	10344429056	INSTRUMENTAIS CIRÚRGICOS EM TI PARA IMPLANTES ZIGOMÁTICOS	Class II
BR	10344420495	INSTRUMENTAIS CIRÚRGICOS EM AÇO INOXIDÁVEL PARA IMPLANTES ZIGOMÁTICOS	Class I

Southern Implants, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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