The Yoshida Dental Mfg. Co., Ltd.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “The Yoshida Dental Mfg. Co., Ltd.” (first 1982, latest 2019), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 74 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 260 |
| 2013 | 1 | 268 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 170 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name The Yoshida Dental Mfg. Co., Ltd. took a median 170 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OAS | X-Ray, Tomography, Computed, Dental | 3 | 3 |
| MUH | System, X-Ray, Extraoral Source, Digital | 2 | 2 |
| EIA | Unit, Operative Dental | 1 | 1 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
Plus 1 more product codes.
Review panels
- Radiology (5)
- Dental (1)
- General and Plastic Surgery (1)
Most recent The Yoshida Dental Mfg. Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K182198 | Panoura X-ERA PF/NF/MF | MUH | 2019-01-31 | 170 |
| K122199 | PREXION3D ECLIPSE | OAS | 2013-04-18 | 268 |
| K120948 | PREXION 3D | OAS | 2012-12-21 | 267 |
| K120932 | OPELASER PRO II AND THE OPELASER LITE II | GEX | 2012-12-07 | 254 |
| K111231 | PANOURA 18S | MUH | 2011-07-13 | 72 |
| K063622 | FINECUBE DENTAL CT | OAS | 2007-02-08 | 65 |
| K000577 | YOSHIDA WAVE PICT CAM INTRAORAL CAMERA, SIGMA BIOMEDICS SIGMACAM INTRAORAL CAMERA | EIA | 2000-05-05 | 73 |
| K837491 | REX PEDESTAL INTRA-ORAL X-RAY UNIT | — | 1983-06-13 | 74 |
| K828325 | YOSHIDA/KAYCOR X-70 X-RAY UNIT | — | 1982-10-21 | 23 |
Recalls
openFDA lists no recalls under a recalling firm named The Yoshida Dental Mfg. Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under The Yoshida Dental Mfg. Co., Ltd.?
FDA lists 9 510(k) clearances under the applicant name “The Yoshida Dental Mfg. Co., Ltd.” (first 1982, latest 2019), across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by The Yoshida Dental Mfg. Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name The Yoshida Dental Mfg. Co., Ltd. is 74 days.
Which FDA product codes appear under The Yoshida Dental Mfg. Co., Ltd.?
The most frequent FDA product codes under this applicant name are OAS (X-Ray, Tomography, Computed, Dental, 3); MUH (System, X-Ray, Extraoral Source, Digital, 2); EIA (Unit, Operative Dental, 1).
Next steps
- See all 9 The Yoshida Dental Mfg. Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code OAS, The Yoshida Dental Mfg. Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.