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Home›China›SHANGHAI SHOFU DENTAL MATERIAL CO. LTD

SHANGHAI SHOFU DENTAL MATERIAL CO. LTD

China · Shanghai
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea — 5 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
19listed device types
Class I 8Class II 10Class III 0unclassified 1
plus 42 registration records and 97 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class I 1
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
1active device licences
Class III 1
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
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 States42 registration records, 97 510(k), 0 PMA, 4 excluded
Brazil1 confirmed, 1 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada1 confirmed, 1 excluded
Manufacturer names merged into this page: SHOFU DENTAL CORP. · SHANGHAI SHOFU DENTAL MATERIAL CO. LTD · SHOFU DENTAL CORPORATION
Same-named companies — This database also contains companies with near-identical names: Shofu Dental Corporation. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
China
City
Shanghai

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

12001
12002
22003
22004
32005
22007
42008
32010
52011
52012
62013
22015
52016
42017
32018
22019
12021
32022
12023
42025

FDA listed device types

showing 8 of 19
Intraoral Camera 1Cement, Dental 1Resin, Denture, Relining, Repairing, Rebasing 1Material, Tooth Shade, Resin 1Powder, Porcelain 1Crown And Bridge, Temporary, Resin 1Agent, Tooth Bonding, Resin 1Powered Laser Surgical Instrument 1

Registration details (sample)

MarketIdentifierNameClass / date
USK252808GlasIonomer FX-LC2025-12-09
USK252165ZIRCONOMER P2025-10-28
USK251470ResiCem EX2025-07-11
BR10258190118ABRASIVOS SHOFUClass I
CA71826MONOCEM SELF ADHESIVE RESIN CEMENTClass III

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