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Hangzhou SHINING3D Dental Technology Co., Ltd.

China · Hangzhou

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Australia, Hong Kong — 7 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

7listed device types

Class I 3Class II 4Class III 0

plus 9 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class II 6

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

3 including historic records

TWTaiwanTFDA

3valid device licences

Class I 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

1valid listings

Class II 1

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 States9 registration records, 5 510(k), 0 PMA

Brazil6 confirmed, 0 excluded

Manufacturer names merged into this page: HANGZHOU SHINING3D DENTAL TECHNOLOGY CO., LTD · HANGZHOU SHINING3D DENTAL TECHNOLOGY CO., LTD.

FDA 510(k) clearances by year

22025 · K253053

32026 · K261356

FDA listed device types

Positioner, Tooth, Preformed 1Accessories, Implant, Dental, Endosseous 1Material, Impression Tray, Resin 1Crown And Bridge, Temporary, Resin 1Material, Tooth Shade, Resin 1Additively Manufactured, Preformed, Resin Denture Tooth 1Resin, Denture, Relining, Repairing, Rebasing 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261356	Dura-Crown	2026-04-27
US	K261261	Dura-Arch	2026-04-17
US	K260170	LumiCera	2026-01-21
BR	82696719012	Dura-Crown	Class II
BR	82696719013	Resina para Base de Prótese	Class II
BR	82696719014	Resina CB Provisória	Class II

Hangzhou SHINING3D Dental Technology Co., Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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