Manufacturer registered with FDA
J. Morita MFG Corp.
KYOTO, Japan. Lists 11 dental device types with FDA across 2 registered establishments.
- Device types listed
- 11
- Brands and models
- 36
- 510(k) clearances
- 0as applicant
- Markets registered in
- 534 registrations outside the US
- Establishments
- 2Japan
Registered in 5 markets
Where regulators' registries name J. Morita MFG Corp. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | J. Morita MFG Corp. | 11 device types | — | Below |
| Taiwan | TFDA | Manufacturer | J. MORITA MFG. CORP.J. MORITA MFG. CORP. TOTTORI FACTORY · J.MORITA MFG. CORP. | 16 | 2006–2024 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | J. MORITA MFG. CORP. | 8 | 2015–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | J. MORITA MFG. CORPJ. Morita Mfg. Corp. · J. Morita MFG Corp. | 8 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | J. MORITA MFG. CORP. | 2 | 2024–2024 | 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 MFG Corp. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | MODEL XDP1Veraview FX800 Model X800NVERAVIEW IC 5Veraview X800Veraviewepocs Model X550 | 2006 |
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | Air SolfyAIR TORXARETE Handpiece Maintenance UnitLUBRICARELubricare 2LUBRINALUBRINA 2Sterling ExpressSTERLING Handpiece Maintenance System | 2007 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | EndoSyncEndoSync PlusLS OILRoot ZX IITRI AUTO MINITri Auto ZX2 | 2008 |
| Dental Computed Tomography X-RayOAS · Class 2 | Dental CBCT | Maker | Veraview FX800 Model X800NVeraview X800 | 2017 |
| Dental Belt and/or Gear Driven HandpieceEFA · Class 1 | Dental handpieces | Maker | ARETEHIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWINPOWER TURBINE 4H)Midwest 45STERLINGXLR8 Plus | 2006 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | TORQTECH | 2012 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | BEACH MOUTH MIRROR | 2002 |
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | FEEL 21 DENTAL OPERATING LIGHTLUNA-VUE DENTAL OPERATING LIGHT | 2004 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Maker | Root ZX II | 2008 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | MODEL CU580SPACELINE EMCIA | 2006 |
| Dental Electrosurgical Unit and AccessoriesEKZ · Class 2 | — | Maker | ROOT ZX3RZX3 | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
J. Morita MFG Corp. 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: J. Morita USA, Inc. (16).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 3 Aug 2022 | K213477 | Root ZX3 | J. Morita USA, Inc. | EKZ Dental Electrosurgical Unit and Accessories |
| 18 Feb 2021 | K201378 | 3D Accuitomo 150N | J. Morita USA, Inc. | OAS Dental Computed Tomography X-Ray |
| 4 Mar 2020 | K190509 | Lubrina 2 | J. Morita USA, Inc. | EFB Dental Air-Powered Handpiece |
| 11 Oct 2018 | K173920 | LS OIL | J. Morita USA, Inc. | EKX Ac-Powered Direct Drive Handpiece |
| 19 Dec 2017 | K171012 | Veraview X800 | J. Morita USA, Inc. | OAS Dental Computed Tomography X-Ray |
| 11 Sep 2017 | K170275 | Tri Auto ZX2 | J. Morita USA, Inc. | EKX Ac-Powered Direct Drive Handpiece |
| 4 May 2012 | K112665 | TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE | J. Morita USA, Inc. | EKX Ac-Powered Direct Drive Handpiece |
| 20 Jan 2012 | K103697 | TORQTECH | J. Morita USA, Inc. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 16 Oct 2009 | K091065 | AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4 | J. Morita USA, Inc. | EFB Dental Air-Powered Handpiece |
| 8 Apr 2008 | K073696 | VERAVIEWEPOCS | J. Morita USA, Inc. | MUH Digital Extraoral Source X-Ray System |
| 17 Aug 2007 | K071190 | ROOT ZX II | J. Morita USA, Inc. | EKX Ac-Powered Direct Drive Handpiece |
| 31 May 2007 | K070074 | LUBRINA, MODEL HIM-1 | J. Morita USA, Inc. | EFB Dental Air-Powered Handpiece |
| 25 Aug 2006 | K061701 | HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H) | J. Morita USA, Inc. | EFA Dental Belt and/or Gear Driven Handpiece |
| 6 Jan 2006 | K053220 | VERAVIEW IC 5, MODEL XDP1 | J. Morita USA, Inc. | MUH Digital Extraoral Source X-Ray System |
| 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 | J. Morita USA, Inc. | EFB Dental Air-Powered Handpiece |
| 16 Feb 2005 | K043496 | SPACELINE EMCIA, MODEL CU580 | J. Morita USA, Inc. | EIA Operative Dental Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| J. MORITA MFG. CORP.FDA reg. 3002807636 | FUSHIMI-KU Kyoto, Japan | Contract manufacturer, Foreign exporter, Manufacturer |
| J. MORITA MFG. CORP., TOTTORI FACTORYFDA reg. 3010281549 | Kurayoshi Tottori, Japan | Manufacturer |
Other names on FDA records
J. Morita MFG. Corp. Tottori Factory
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9048647). 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.