Data / Medical devices / Japan / J. Morita MFG. Corp.
J. Morita MFG. Corp.: FDA-registered device maker in FUSHIMI-KU Kyoto, Japan, 20 510(k) clearances
J. Morita MFG. Corp. is registered with the FDA (registration 3002807636) in FUSHIMI-KU Kyoto, Japan. It lists 15 device types. The FDA files 20 510(k) clearances under its listings, the newest dated August 3, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002807636
- Address
- 680 Higashihama Minami-Cho, FUSHIMI-KU Kyoto, Japan, 612-8533
- Owner or operator
- J. MORITA MFG. CORP. (9048647)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- August 12, 2002
- Registered through
- 2026
- Brand names listed
- 3D Accu-I-tomo Model MCT-1EX-1F8/F17, ADVERL EVO ER: YAG LASER FOR DENTISTRY, AIR TORX, ARETE, ARETE Handpiece Maintenance Unit, Air Solfy, BEACH MOUTH MIRROR, EndoSync and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 3, 2022 | K213477 | Root ZX3 | EKZ | Substantially Equivalent | J. Morita USA, Inc. | accessdata.fda.gov |
| February 18, 2021 | K201378 | 3D Accuitomo 150N | OAS | Substantially Equivalent | J. Morita USA, Inc. | accessdata.fda.gov |
| March 4, 2020 | K190509 | Lubrina 2 | EFB | Substantially Equivalent | J. Morita USA, Inc. | accessdata.fda.gov |
| October 11, 2018 | K173920 | LS OIL | EKX | Substantially Equivalent | J. Morita USA, Inc. | accessdata.fda.gov |
| December 19, 2017 | K171012 | Veraview X800 | OAS | Substantially Equivalent | J. Morita USA, Inc. | accessdata.fda.gov |
| September 11, 2017 | K170275 | Tri Auto ZX2 | EKX | Substantially Equivalent | J. Morita USA, Inc. | accessdata.fda.gov |
| July 25, 2012 | K120377 | ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A | GEX | Substantially Equivalent | J. Morita USA, Inc. | accessdata.fda.gov |
| May 4, 2012 | K112665 | TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE | EKX | Substantially Equivalent | J. Morita USA, Inc. | accessdata.fda.gov |
| January 20, 2012 | K103697 | TORQTECH | EGS | Substantially Equivalent | J. Morita USA, Inc. | accessdata.fda.gov |
| November 23, 2009 | K090925 | MULTIPLE (APEX LOCATOR), MODEL RCM-7 | LQY | Substantially Equivalent | J. Morita USA, Inc. | accessdata.fda.gov |
| October 16, 2009 | K091065 | AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4 | EFB | Substantially Equivalent | J. Morita USA, Inc. | accessdata.fda.gov |
| April 9, 2008 | K073695 | 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17 | JAK | Substantially Equivalent | J. Morita USA, Inc. | accessdata.fda.gov |
| April 8, 2008 | K073696 | VERAVIEWEPOCS | MUH | Substantially Equivalent | J. Morita USA, Inc. | accessdata.fda.gov |
| February 21, 2008 | K073704 | I-DIXEL | LLZ | Substantially Equivalent | J. Morita USA, Inc. | accessdata.fda.gov |
| August 17, 2007 | K071190 | ROOT ZX II | EKX | Substantially Equivalent | J. Morita USA, Inc. | accessdata.fda.gov |
| May 31, 2007 | K070074 | LUBRINA, MODEL HIM-1 | EFB | Substantially Equivalent | J. Morita USA, Inc. | accessdata.fda.gov |
| August 25, 2006 | K061701 | HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H) | EFA | Substantially Equivalent | J. Morita USA, Inc. | accessdata.fda.gov |
| January 6, 2006 | K053220 | VERAVIEW IC 5, MODEL XDP1 | MUH | Substantially Equivalent | J. Morita USA, Inc. | accessdata.fda.gov |
| March 21, 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 | Substantially Equivalent | J. Morita USA, Inc. | accessdata.fda.gov |
| February 16, 2005 | K043496 | SPACELINE EMCIA, MODEL CU580 | EIA | Substantially Equivalent | J. Morita USA, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Handpiece, Direct Drive, Ac-Powered
- All makers of Handpiece, Air-Powered, Dental
- All makers of System, X-Ray, Tomography, Computed
- All makers of Locator, Root Apex
- All makers of Unit, Operative Dental
- All makers of System, X-Ray, Extraoral Source, Digital
Updated August 3, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.