HomeJapanKuraray Noritake Dental, Inc.

Kuraray Noritake Dental, Inc.

Japan · Kurashiki
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Australia, Israel, Russia — 8 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
12listed device types
Class I 3Class II 9Class III 0
plus 58 registration records and 32 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
50registered devices
Class I 1Class II 49
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
31active device licences
Class III 31
81 including historic records
TWTaiwanTFDA
2valid device licences
Class I 1Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
10active ARTG entries
IIa 10
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
11active registrations
Class 2a 11
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 States58 registration records, 32 510(k), 0 PMA, 1 excluded
Brazil50 confirmed, 0 excluded
Canada31 confirmed, 0 excluded
Manufacturer names merged into this page: KURARAY NORITAKE DENTAL NIIGATA PLANT · KURARAY NORITAKE DENTAL INC. MIYOSHI PLANT · KURARAY NORITAKE DENTAL INC. · Kuraray Noritake Dental Inc. · KURARAY NORITAKE DENTAL INC

Company information

Country
Japan
City
Kurashiki

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

32012
72013
12014
52015
22016
22017
52019
12020
12021
22022
12023
12024
12025

FDA listed device types

showing 8 of 12
Device, Caries Detection 1Cement, Dental 1Liner, Cavity, Calcium Hydroxide 1External Cleaning Solution 1Abutment, Implant, Dental, Endosseous 1Material, Tooth Shade, Resin 1Varnish, Cavity 1Powder, Porcelain 1

Registration details (sample)

MarketIdentifierNameClass / date
USK250673CERABIEN MiLai2025-05-29
USK233285KATANA Zirconia ONE For IMPLANT2024-05-24
USK231039CLEARFIL Universal Bond Quick 22023-12-13
BR81777910003PANAVIA V5 PASTAClass II
BR81777910014PANAVIA V5 COLOR KITClass II
BR81777910004PANAVIA V5 INTRODUCTORY KITClass II
CA4314CLEARFIL LINER BOND SYSTEMClass III
CA4318CLEARFIL FII NEW BONDClass III
CA4320CLEARFIL CR INLAYClass III

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