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NuSmile, Ltd.

USA · Houston

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 9 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

22listed device types

Class I 14Class II 6Class III 0unclassified 2

plus 27 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class II 8

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

5registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

3active device licences

Class II 2Class III 1

14 including historic records

TWTaiwanTFDA

3valid device licences

Class I 1Class II 2

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

IIa 3

HKHong KongMDACS

2valid listings

Class II 2

ILIsraelAMAR

1registrations

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 States27 registration records, 1 510(k), 0 PMA

Brazil8 confirmed, 0 excluded

Saudi Arabia5 confirmed, 0 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: NUSMILE, LTD · NUSMILE, LTD. · NUSMILE LTD · NuSmile, LTD

FDA 510(k) clearances by year

12019 · K181917

FDA listed device types

showing 8 of 22

Sealant, Pit And Fissure, And Conditioner 1Cement, Dental 1Liner, Cavity, Calcium Hydroxide 1Diammine Silver Fluoride Dental Hypersensitivity Varnish 1Varnish, Cavity 1Resin, Root Canal Filling 1Instruments, Dental Hand 1Handpiece, Direct Drive, Ac-Powered 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K181917	MTA2.3 MATERIALS	2019-01-11
BR	81890179001	Bioactive Bioceramics NeoMTA 2	Class II
BR	81890179002	Coroas ZR NuSmile	Class II
BR	81890179003	NeoPUTTY	Class II
SA	ME0000020447SFDAA00007	NuSmile ® ZR Zirconia Crowns	—
SA	ME0000020447SFDAA00006	NuSmile Signature Crowns	—
CA	93424	GREY MTA PLUS ROOT & PULP TREATMENT MATERIAL	Class III
CA	94755	NUSMILE PEDIATRIC CROWNS DENTAL CARBIDE BURS	Class II
CA	94756	NUSMILE PEDIATRIC CROWNS DENTAL BURS	Class II

NuSmile, 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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