Manufacturer registered with FDA
The Yoshida Dental Mfg. Co., Ltd.
TOKYO, Japan. Lists 1 dental device type with FDA across 2 registered establishments, and holds 6 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 4
- 510(k) clearances
- 62000–2019
- Markets registered in
- 533 registrations outside the US
- Establishments
- 2Japan
510(k) clearances per year, 2000–2026
Registered in 5 markets
Where regulators' registries name The Yoshida Dental Mfg. Co., Ltd. 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 | The Yoshida Dental Mfg. Co., Ltd. | 6 clearances | 2000–2019 | Below |
| Taiwan | TFDA | Manufacturer | THE YOSHIDA DENTAL MFG CO. LTD.THE YOSHIDA DENTAL MFG CO., LTD. · MD INSTRUMENTS MFG. CO., LTD · +2 | 22 | 1977–2020 | Pure Global AI |
| South Korea | MFDS | Manufacturer | THE YOSHIDA DENTAL MFG. CO.,LTD.THE YOSHIDA DENTAL MFG CO., LTD · THE YOSHIDA DENTAL MFG, CO., LTD · +2 | 8 | 2001–2016 | Pure Global AI |
| Canada | Health Canada | Registration holder | YOSHIDA DENTAL MFG.CO.LTD. | 2 | 2002–2002 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | The Yoshida Dental Mfg. Co., Ltd. | 1 | — | 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 The Yoshida Dental Mfg. Co., Ltd. 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 | ImageWorks PanouraPanoura 18SPanoura X-ERAX-era Smart | 2011 |
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 The Yoshida Dental Mfg. Co., Ltd. as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 31 Jan 2019 | K182198 | Panoura X-ERA PF/NF/MF | MUH Digital Extraoral Source X-Ray System |
| 18 Apr 2013 | K122199 | PREXION3D ECLIPSE | OAS Dental Computed Tomography X-Ray |
| 21 Dec 2012 | K120948 | PREXION 3D | OAS Dental Computed Tomography X-Ray |
| 13 Jul 2011 | K111231 | PANOURA 18S | MUH Digital Extraoral Source X-Ray System |
| 8 Feb 2007 | K063622 | FINECUBE DENTAL CT | OAS Dental Computed Tomography X-Ray |
| 5 May 2000 | K000577 | YOSHIDA WAVE PICT CAM INTRAORAL CAMERA, SIGMA BIOMEDICS SIGMACAM INTRAORAL CAMERA | EIA Operative Dental Unit |
Also lists devices cleared under other names
The Yoshida Dental Mfg. Co., Ltd. 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: Mic International (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 8 Mar 2013 | K122806 | IMAGE WORKS PANOURA | Mic International | MUH Digital Extraoral Source X-Ray System |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MD INSTRUMENTS MFG. CO.,LTD.FDA reg. 3013360312 | Inashiki-Gun Ibaraki, Japan | Contract manufacturer |
| THE YOSHIDA DENTAL MFG. CO., LTD.FDA reg. 9611036 | TOKYO, Japan | Manufacturer |
Other names on FDA records
MD Instruments MFG. Co., Ltd.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8030214). 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.