MARUCHI

Korea, Republic · Wonju-Si Gangwon

✓ Record-verifiedregistrations found in 7 markets

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

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

5listed device types

Class I 3Class II 2Class III 0

plus 8 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class 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

4valid device licences

Class I 1Class II 3

SGSingaporeHSA SMDR

4device registrations

CLASS B 4

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIa 2

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

2registrations

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 States8 registration records, 8 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: MARUCHI

FDA 510(k) clearances by year

12012 · K112078

22014 · K133042

12018 · K170175

32021 · K212229

12023 · K213757

FDA listed device types

Pick, Massaging 1Needle, Dental 1File, Pulp Canal, Endodontic 1Resin, Root Canal Filling 1Liner, Cavity, Calcium Hydroxide 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K213757	Endocem MTA Premixed Regular	2023-02-14
US	K212229	White Endoseal MTA	2021-08-13
US	K202015	White ENDOSEAL MTA	2021-03-24
BR	80745409009	Selante AH Plus® Biocerâmico	Class II

MARUCHI

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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