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J. MORITA USA, INC.

USA · Irvine

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Australia, Israel — 4 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

13listed device types

Class I 7Class II 6Class III 0

plus 14 registration records and 52 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

9active device licences

Class II 6Class III 3

13 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

HKHong KongMDACS

pendingnot queried

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 States14 registration records, 52 510(k), 0 PMA, 5 excluded

Brazil0 confirmed, 1 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada9 confirmed, 1 excluded

Manufacturer names merged into this page: J. MORITA USA, INC. · J. MORITA USA INC.

FDA 510(k) clearances by year

11995

21996

21997

11998

11999

32000

72002

22003

12004

62005

62006

32007

32008

22009

32012

22017

12018

12020

12021

12022

FDA listed device types

showing 8 of 13

Point, Paper, Endodontic 1Unit, Operative Dental 1Accessories, Retractor, Dental 1File, Pulp Canal, Endodontic 1Gutta-Percha 1Post, Root Canal 1Zinc Oxide Eugenol 1Resin, Denture, Relining, Repairing, Rebasing 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K213477	Root ZX3	2022-08-03
US	K201378	3D Accuitomo 150N	2021-02-18
US	K190509	Lubrina 2	2020-03-04
CA	5569	SB POST PRE-SANDBLASTED DENTAL POST SYSTEM	Class III
CA	13239	ATD AUTOMATIC BRIDGE REMOVER	Class II
CA	62791	CARBON FIBER POST SYSTEM	Class III

J. MORITA USA, INC.

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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