Data / Medical devices / Japan / J. Morita MFG. Corp., Tottori Factory
J. Morita MFG. Corp., Tottori Factory: FDA-registered device maker in Kurayoshi Tottori, Japan, 4 510(k) clearances
J. Morita MFG. Corp., Tottori Factory is registered with the FDA (registration 3010281549) in Kurayoshi Tottori, Japan. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 18, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010281549
- Address
- 608 Tani, Kurayoshi Tottori, Japan, 682-0954
- Owner or operator
- J. MORITA MFG. CORP. (9048647)
- Roles
- Manufacturer
- First device listed
- September 6, 2006
- Registered through
- 2026
- Brand names listed
- ARETE, HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWINPOWER TURBINE 4H), Midwest 45, STERLING, TORQTECH, Veraview FX800 Model X800N, Veraview X800, XLR8 Plus
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Handpiece, Belt And/Or Gear Driven, Dental | EFA | 1 | Manufacturer | accessdata.fda.gov |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | 1 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Extraoral Source, Digital | MUH | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Manufacturer | accessdata.fda.gov |
| X-Ray, Tomography, Computed, Dental | OAS | 2 | Manufacturer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| February 18, 2021 | K201378 | 3D Accuitomo 150N | OAS | 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 |
| January 20, 2012 | K103697 | TORQTECH | EGS | 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 |
Compare with other makers
- All makers of System, X-Ray, Extraoral Source, Digital
- All makers of X-Ray, Tomography, Computed, Dental
- All makers of Handpiece, Contra- And Right-Angle Attachment, Dental
- All makers of System, X-Ray, Tomography, Computed
- All makers of Handpiece, Belt And/Or Gear Driven, Dental
Updated February 18, 2021. 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.