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IVOCLAR VIVADENT GMBH & CO. KG

Canada · Amherst

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Russia — 10 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

39listed device types

Class I 18Class II 21Class III 0

plus 385 registration records and 98 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

109registered devices

Class I 11Class II 98

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

SASaudi ArabiaSFDA

36registered imported devices

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

CACanadaMDALL

38active device licences

Class I 3Class II 13Class III 22

129 including historic records

TWTaiwanTFDA

85valid device licences

Class I 13Class II 72

SGSingaporeHSA SMDR

31device registrations

CLASS B 30CLASS C 1

KRSouth KoreaMFDS GMP

8GMP quality-system certificates

Import 8

AUAustraliaTGA ARTG

35active ARTG entries

Class I 11IIa 22IIb 2

HKHong KongMDACS

4valid listings

Class II 4

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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 States385 registration records, 98 510(k), 0 PMA, 1 excluded

Brazil109 confirmed, 0 excluded

Saudi Arabia36 confirmed, 0 excluded

Canada38 confirmed, 0 excluded

Manufacturer names merged into this page: IVOCLAR VIVADENT, INC. · Ivoclar Vivadent GmbH · IVOCLAR VIVADENT AG · Ivoclar Vivadent Manufacturing, Inc · IVOCLAR VIVADENT INC. · Ivoclar Vivadent Manufacturing GmbH

FDA 510(k) clearances by year

92004

32005

52006

42007

62009

32010

62011

62012

52013

42014

52015

32016

12017

12018

52019

22020

12021

12022

12024

32026

FDA listed device types

showing 8 of 39

Alloy, Amalgam 1Sealant, Pit And Fissure, And Conditioner 1Activator, Ultraviolet, For Polymerization 1Teeth, Porcelain 1Abutment, Implant, Dental, Endosseous 1Material, Impression 1Powder, Porcelain 1Denture, Plastic, Teeth 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261485	Tetric plus Fill;Tetric plus Flow	2026-07-01
US	K253953	IPS e.max Zirconia	2026-03-10
US	K252450	Adhese 2	2026-03-05
BR	80091440029	CERAMICAS IPS D. SIGN IVOCLAR VIVADENT	Class II
BR	80091440022	DENTES ARTIFICIAIS IVOCLAR VIVADENT	Class II
BR	80091440141	IPS Empress Direct Effect	Class II
SA	ME0000000609SFDAA00001	Mixing Tips Refill blue tapered 50	—
SA	ME0000000609SFDAA00002	MultiCore Flow Intra Oral Tips Ref10	—
CA	8931	WILLIAM DEADSOFT PLATINUM FOIL	Class I
CA	10496	WILLIAMS E-Z GOLD	Class III
CA	65877	ODYSSEY DIODE LASER	Class III

IVOCLAR VIVADENT GMBH & CO. KG

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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