Manufacturer registered with FDA

J. Morita USA, Inc.

Irvine, CA, United States. Lists 15 dental device types with FDA across 2 registered establishments, and holds 42 510(k) clearances as applicant.

FDA owner/operator8030247Foreign exporterRepacker / relabelerSpecification developer1 clearance in five years

Device types listed: 15
Brands and models: 13
510(k) clearances: 421988–2022
Markets registered in: 8103 registrations outside the US
Establishments: 2Japan, United States

510(k) clearances per year, 1980–2026

Registered in 8 markets

Where regulators' registries name J. Morita USA, Inc. as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: United StatesOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Manufacturer	J. Morita USA, Inc.	42 clearances	1988–2022	Below
Canada	Health Canada	Registration holder	J. MORITA USA INC.	51	1999–2006	Pure Global AI
Australia	TGA	Registration holder	J Morita CorporationJ Morita USA Inc	26	2005–2026	Pure Global AI
Taiwan	TFDA	Manufacturer	J. MORITA CORPORATIONJ. MORITA CORP.	14	1976–2023	Pure Global AI
Costa Rica	Ministerio de Salud	Manufacturer	J. MORITA USA, INC.JMORITA USA INC	8	—	Pure Global AI
Israel	AMAR	Manufacturer	J.Morita USA Inc.	2	—	Pure Global AI
Colombia	INVIMA	Manufacturer	J. MORITA USA INC	1	—	Pure Global AI
South Korea	MFDS	Manufacturer	J.Morita USA Inc	1	2001–2001	Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What J. Morita USA, Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Root Canal PostELR · Class 1	Root canal filling materials	Lister	CF Carbon Fiber PostGF Glass Fiber Post	2008
Dental NeedleDZM · Class 1	Dental needles & syringes	Lister	MORITA DISPOSABLE DENTAL NEEDLE	1998
Resin Tooth Shade MaterialEBF · Class 2	Dental composites	Maker	FormCore DC Core Build-up Material	2006
Resin Temporary Crown and BridgeEBG · Class 2	Temporary crown & bridge materials	Maker	CB Temp Temporary Crown & Bridge Material	2007
Rebasing Repairing Relining Denture ResinEBI · Class 2	Denture resins & teeth	Maker	SilkLine Soft Denture Relining Material	2006
Operative Dental UnitEIA · Class 1	Dental chairs & operative units	Lister	—	2025
Dental Retractor AccessoriesEIF · Class 1	Dental hand instruments	Maker	Free Access II Lip & Cheek Retractor	2001
Operative Dental Amalgam CarverEKH · Class 1	Dental hand instruments	Lister	Amalgam Carver	2009
Gutta-PerchaEKM · Class 1	Root canal filling materials	Lister	—	2026
Endodontic Paper PointEKN · Class 1	Root canal filling materials	Lister	—	2026
Endodontic Pulp Canal FileEKS · Class 1	Endodontic files	Lister	RootFlex	2025
Impression MaterialELW · Class 2	Impression materials	Maker	Perfectim Systems	2007
Zinc Oxide EugenolEMB · Class 1	Dental cements	Maker	Power Temp(TM) Temporary Cement	2007
Resin Tooth Bonding AgentKLE · Class 2	Bonding agents	Maker	Max Bond LC Self-etching Bonding Agent	2006
Synthetic Bone Grafting MaterialLYC · Class 2	Bone grafts & membranes	Lister	Foundation	2014

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names J. Morita USA, Inc. as the applicant, including filings under its other names.

Decided	510(k)	Device	Device type
3 Aug 2022	K213477	Root ZX3	EKZ Dental Electrosurgical Unit and Accessories
18 Feb 2021	K201378	3D Accuitomo 150N	OAS Dental Computed Tomography X-Ray
4 Mar 2020	K190509	Lubrina 2	EFB Dental Air-Powered Handpiece
11 Oct 2018	K173920	LS OIL	EKX Ac-Powered Direct Drive Handpiece
19 Dec 2017	K171012	Veraview X800	OAS Dental Computed Tomography X-Ray
11 Sep 2017	K170275	Tri Auto ZX2	EKX Ac-Powered Direct Drive Handpiece
4 May 2012	K112665	TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE	EKX Ac-Powered Direct Drive Handpiece
20 Jan 2012	K103697	TORQTECH	EGS Dental Contra- and Right-Angle Attachment Handpiece
16 Oct 2009	K091065	AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4	EFB Dental Air-Powered Handpiece
8 Apr 2008	K073696	VERAVIEWEPOCS	MUH Digital Extraoral Source X-Ray System
17 Aug 2007	K071190	ROOT ZX II	EKX Ac-Powered Direct Drive Handpiece
31 May 2007	K070074	LUBRINA, MODEL HIM-1	EFB Dental Air-Powered Handpiece
5 Jan 2007	K063529	PENCURE, MODEL VL-7	EBZ Ultraviolet Activator for Polymerization
8 Sep 2006	K061664	FORMCORE DC, MODEL 28-700100	EBF Resin Tooth Shade Material
1 Sep 2006	K060882	EXCEL BOND DC, MODEL 28-200100	KLE Resin Tooth Bonding Agent
25 Aug 2006	K061701	HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H)	EFA Dental Belt and/or Gear Driven Handpiece
6 Jun 2006	K060844	SILKLINE SOFT RELINING KIT, MODEL 28-100100	EBI Rebasing Repairing Relining Denture Resin
2 Jun 2006	K061322	PORCELAIN PRIMER	KLE Resin Tooth Bonding Agent
6 Jan 2006	K053220	VERAVIEW IC 5, MODEL XDP1	MUH Digital Extraoral Source X-Ray System
7 Nov 2005	K053030	J. MORITA AZ ULTRASONIC SYSTEM	ELC Ultrasonic Scaler
28 Jul 2005	K051780	JETLITE 5000	EBZ Ultraviolet Activator for Polymerization
21 Mar 2005	K043497	AIR SOLFY, MODELS AS-4H, AS-4H-O, AS-4H-V, AS-4H-OV, AS-1,AS-1-0,AS-1-V, AS-1-OV	EFB Dental Air-Powered Handpiece
16 Feb 2005	K043498	TWIN POWER TURBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECE	EFB Dental Air-Powered Handpiece
16 Feb 2005	K043496	SPACELINE EMCIA, MODEL CU580	EIA Operative Dental Unit
30 Sep 2004	K042056	AZ ULTRASONIC SYSTEM	ELC Ultrasonic Scaler
21 Aug 2003	K031204	DENTAPORT ZX	EKX Ac-Powered Direct Drive Handpiece
7 Jun 2002	K021372	VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY	EAG Cephalometer
17 May 2002	K012496	CARBON POST	ELR Root Canal Post
27 Mar 2002	K012849	GLASS POST	ELR Root Canal Post
7 Mar 2002	K020158	NON-EUGENOL TEMPORARY CEMENT	EMB Zinc Oxide Eugenol
4 Mar 2002	K020157	TEMPORARY CROWN AND BRIDGE MATERIAL	EBG Resin Temporary Crown and Bridge
4 Feb 2002	K013955	VERAVIEWEPOCS, MODEL VE	EHD Extraoral with Timer X-Ray Unit
15 May 2000	K000078	JETLITE 4000	EBZ Ultraviolet Activator for Polymerization
31 Jan 2000	K992648	ROTARY MASTER	EBW Handpiece and Cord Foot Controller
29 Oct 1999	K992649	ATD AUTOMATIC BRIDGE REMOVER	EIS Crown Remover
20 Jan 1998	K974077	VERSAVIEW PANORAMIC-CEPHALOMETRIC DENTAL X-RAY SYS.	EHD Extraoral with Timer X-Ray Unit
4 Jun 1997	K970339	TRI AUTO ZX	EKX Ac-Powered Direct Drive Handpiece
25 Feb 1997	K964692	PERFECTIM	ELW Impression Material
24 Oct 1996	K963110	JETLITE	EBZ Ultraviolet Activator for Polymerization
20 Mar 1996	K953865	SPACELINE FEEL 21	EFA Dental Belt and/or Gear Driven Handpiece
14 Aug 1990	K901037	VISIONER 21-A	EKS Endodontic Pulp Canal File
22 Dec 1988	K884277	AD POST	ELR Root Canal Post

Some of these clearances are listed with FDA today by another company: J. Morita MFG Corp. (16), Bien-Air Dental, SA (2), Peter Brasseler Holdings, LLC (2), Dentsply Sirona, Inc. (1), Nakanishi, Inc. (1).

Also lists devices cleared under other names

J. Morita USA, Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Lares Research (1), Olympus Terumo Biomaterials Corporation (1).

Decided	510(k)	Device	Applicant	Device type
15 Dec 2022	K220873	Perceptive electric dental motor and control unit	Lares Research	EIA Operative Dental Unit
29 Nov 2011	K111087	FOUNDATION	Olympus Terumo Biomaterials Corporation	LYC Synthetic Bone Grafting Material

Registered establishments

Establishment	Location	What it does
J. MORITA CORP.FDA reg. 3006606966	TARUMI-CHO Osaka, Japan	Foreign exporter
J. MORITA USA, INC.FDA reg. 2081055	IRVINE, CA, United States	Repacker / relabeler, Specification developer

Other names on FDA records

J. Morita Corporation

Sources

FDA establishment registration & device listing (search FDA, owner/operator 8030247). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.