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Hunan Vsmile Biotechnology Co., Ltd.

China · Changsha Hunan

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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

6listed device types

Class I 1Class II 4Class III 0unclassified 1

plus 7 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 1Class II 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

0active device licences

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 States7 registration records, 2 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Manufacturer names merged into this page: HUNAN VSMILE BIOTECHNOLOGY CO.,LTD · HUNAN VSMILE BIOTECHNOLOGY CO., LTD

FDA 510(k) clearances by year

12022 · K221242

12024 · K242407

FDA listed device types

Crown And Bridge, Temporary, Resin 1System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 1Resin, Denture, Relining, Repairing, Rebasing 1Powder, Porcelain 1Mouthguard, Prescription 1Wax, Dental, Intraoral 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242407	Dental Glass Ceramics Blocks (HT, LT, MT)	2024-11-13
US	K221242	Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank	2022-07-29
BR	81762000002	Bloco de zircônia	Class II
BR	81762000003	FRESA PARA CAD/CAM	Class I

Hunan Vsmile Biotechnology 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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