Data / Medical devices / Japan / The Yoshida Dental MFG. Co., Ltd.
The Yoshida Dental MFG. Co., Ltd.: FDA-registered device maker in Tokyo, Japan, 4 510(k) clearances
The Yoshida Dental MFG. Co., Ltd. is registered with the FDA (registration 9611036) in Tokyo, Japan. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 31, 2019. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9611036
- FEI number
- 3002809599
- Address
- 1-3-6, Kotobashi, Sumida-Ku, Tokyo, Japan, 130 8516
- Owner or operator
- THE YOSHIDA DENTAL MFG. CO., LTD. (8030214)
- Roles
- Manufacturer
- First device listed
- July 15, 2011
- Registered through
- 2027
- Brand names listed
- ImageWorks Panoura, Mielscope, Mielscope +, Opelaser Lite II, Opelaser PRO II, Panoura 18S, Panoura X-ERA, X-era Smart
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Microscope, Surgical | EPT | 1 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Extraoral Source, Digital | MUH | 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 |
|---|---|---|---|---|---|---|
| January 31, 2019 | K182198 | Panoura X-ERA PF/NF/MF | MUH | Substantially Equivalent | The Yoshida Dental Mfg. Co., Ltd. | accessdata.fda.gov |
| March 8, 2013 | K122806 | IMAGE WORKS PANOURA | MUH | Substantially Equivalent | Mic International | accessdata.fda.gov |
| December 7, 2012 | K120932 | OPELASER PRO II AND THE OPELASER LITE II | GEX | Substantially Equivalent | The Yoshida Dental Mfg. Co., Ltd. | accessdata.fda.gov |
| July 13, 2011 | K111231 | PANOURA 18S | MUH | Substantially Equivalent | The Yoshida Dental Mfg. Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of System, X-Ray, Extraoral Source, Digital
- All makers of Microscope, Surgical
Updated January 31, 2019. 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.