The Yoshida Dental Mfg. Co., Ltd.
Country not established FDA
- Devices
- 9
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What The Yoshida Dental Mfg. Co., Ltd. makes
The Yoshida Dental Mfg. Co., Ltd. manufactures intraoral X-ray units, including the REX Pedestal and Yoshida/Kaycor X-70, as well as panoramic X-ray systems like the Panoura X-ERA (PF/NF/MF) and Panoura 18S. Their portfolio also includes intraoral cameras such as the Yoshida Wave PICt Cam and Sigma Biomedics Sigmacam, alongside dental cone-beam CT systems like the FineCube Dental CT. Additionally, they produce 3D imaging devices, including the Prexion3D Eclipse and Prexion 3D, and dental lasers such as the Opelaser Pro II and Opelaser Lite II.
These devices are classified under FDA’s Class I and Class II categories, with regulatory submissions supported through the 510(k) pathway. The company’s products are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
PREXION3D Eclipse Ref K122199
Regimes: 510(k) Registry: 510(k)Panoura X-ERA PF/NF/MF Ref K182198
Regimes: 510(k) Registry: 510(k)Opelaser Pro Ii And The Opelaser Lite Ii Ref K120932
Regimes: 510(k) Registry: 510(k)Rex Pedestal Intra-Oral X-Ray Unit Ref K837491
Regimes: 510(k) Registry: 510(k)Yoshida/Kaycor X-70 X-Ray Unit Ref K828325
Regimes: 510(k) Registry: 510(k)Panoura 18S Ref K111231
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Finecube Dental Ct Ref K063622
Regimes: 510(k) Registry: 510(k)Prexion 3D Ref K120948
Regimes: 510(k) Registry: 510(k)
FDA establishments
- The Yoshida Dental Mfg. Co., Ltd. TOKYO · JP FEI 3002809599
Frequently asked questions
How many devices does The Yoshida Dental Mfg. Co., Ltd. have in the registry?
The registry currently lists 9 devices for The Yoshida Dental Mfg. Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list The Yoshida Dental Mfg. Co., Ltd.'s devices?
Among its 9 most recently registered devices, The Yoshida Dental Mfg. Co., Ltd. has devices listed in FDA 510(k) (9 devices).
What risk classes do The Yoshida Dental Mfg. Co., Ltd.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for The Yoshida Dental Mfg. Co., Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from The Yoshida Dental Mfg. Co., Ltd. in the registry?
The most recently registered devices listed for The Yoshida Dental Mfg. Co., Ltd. include PREXION3D ECLIPSE, Panoura X-ERA PF/NF/MF, OPELASER PRO II AND THE OPELASER LITE II and REX PEDESTAL INTRA-ORAL X-RAY UNIT.
Which FDA establishments are linked to The Yoshida Dental Mfg. Co., Ltd.?
1 FDA establishment is linked to The Yoshida Dental Mfg. Co., Ltd. in the registry; they are listed on the company page.