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Huge Dental Material Co., Ltd.

China · Rizhao City
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Russia — 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
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
17listed device types
Class I 7Class II 9Class III 0unclassified 1
plus 23 registration records and 11 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
11registered devices
Class I 3Class II 8
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
12 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
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 States23 registration records, 11 510(k), 0 PMA, 3 excluded
Brazil11 confirmed, 0 excluded
Manufacturer names merged into this page: Shandong Huge Dental Material Corporation · SHANDONG HUGE DENTAL MATERIAL CORPORATION · Huge Dental Material Co., Ltd.
Same-named companies — This database also contains companies with near-identical names: Shandong Huge Dental Material Corporation. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
China
City
Rizhao City

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

12010
12016
12017
12019
22020
22022
12025
22026

FDA listed device types

showing 8 of 17
Cement, Dental 1Resin, Denture, Relining, Repairing, Rebasing 1Material, Tooth Shade, Resin 1Material, Impression 1Denture, Plastic, Teeth 1Powder, Porcelain 1Crown And Bridge, Temporary, Resin 1Alloy, Other Noble Metal 1

Registration details (sample)

MarketIdentifierNameClass / date
USK260376Denture Base2026-05-06
USK260067Eternal Art Porcelain Powders2026-04-09
USK251252NOBILCAM IMPAK Disc2025-08-01
BR81707000012Blocos em PMMA para Prótese Dentária Removível ou TemporáriaClass I
BR81707009004Dente de Polímero SintéticoClass II
BR80476699004Resinas para Base de Prótese DentáriaClass II

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