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Ultradent Products, Inc.

USA · South Jordan

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

47listed device types

Class I 28Class II 17Class III 0unclassified 2

plus 101 registration records and 110 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

38registered devices

Class I 16Class II 22

43 including historic records

SASaudi ArabiaSFDA

42registered imported devices

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

CACanadaMDALL

10active device licences

Class II 7Class III 3

45 including historic records

TWTaiwanTFDA

49valid device licences

Class I 27Class II 22

SGSingaporeHSA SMDR

31device registrations

CLASS B 31

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

50active ARTG entries

Class I 31IIa 19

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

28active registrations

Class 1 2Class 2a 26

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 States101 registration records, 110 510(k), 0 PMA

Brazil38 confirmed, 1 excluded

Saudi Arabia42 confirmed, 0 excluded

Canada10 confirmed, 0 excluded

Manufacturer names merged into this page: Ultradent Products Inc. · ULTRADENT PRODUCTS, INC. · ULTRADENT PRODUCTS INC · ULTRADENT PRODUCTS INC. · Ultradent products Inc

FDA 510(k) clearances by year

32004

32005

52006

32007

22008

22009

42010

52011

12012

42013

32015

12016

12018

12019

12020

32021

22022

12023

22024

22026

FDA listed device types

showing 8 of 47

Handpiece, Air-Powered, Dental 1Evacuator, Oral Cavity 1Syringe, Restorative And Impression Material 1Pick, Massaging 1Material, Impression Tray, Resin 1Accessories To Examination Light 1Instruments, Dental Hand 1Disk, Abrasive 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K262228	Transcend Bulk Fill Flowable Composite	2026-07-01
US	K261404	UltraEZ	2026-04-30
US	K240743	Peak Universal Bond	2024-03-20
BR	80279910108	EASE-IN-SHIELDS	Class I
BR	80279910066	FORMA	Class II
BR	80279910068	ULTRAEZ TRAY	Class I
SA	ME0000015243SFDAA00045	Ultradent™ Diamond Polish	—
SA	ME0000015243SFDAA00043	Valo Grand Cordless	—
CA	73628	RITANO ACCESS BURS	Class II
CA	82632	ENDO-EZE TILOS NITI FILES	Class II
CA	82763	ENDO-EZE STAINLESS STEEL FILES	Class II