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Home›USA›Ultradent Product, Inc.

Ultradent Product, Inc.

USA · South Jordan
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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 106 510(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
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 States101 registration records, 106 510(k), 0 PMA, 3 excluded
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
Same-named companies — This database also contains companies with near-identical names: Ultradent Products, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
South Jordan

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

22003
32004
32005
52006
32007
22008
22009
42010
52011
22013
22015
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)

MarketIdentifierNameClass / date
USK262228Transcend Bulk Fill Flowable Composite2026-07-01
USK261404UltraEZ2026-04-30
USK240743Peak Universal Bond2024-03-20
BR80279910108EASE-IN-SHIELDSClass I
BR80279910066FORMAClass II
BR80279910068ULTRAEZ TRAYClass I
SAME0000015243SFDAA00045Ultradent™ Diamond Polish—
SAME0000015243SFDAA00043Valo Grand Cordless—
CA73628RITANO ACCESS BURSClass II
CA82632ENDO-EZE TILOS NITI FILESClass II
CA82763ENDO-EZE STAINLESS STEEL FILESClass II

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