Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
The Yoshida Dental Mfg. Co., Ltd. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
74 daysmedian FDA review time
268 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K182198 | Panoura X-ERA PF/NF/MF | The Yoshida Dental Mfg. Co., Ltd. | 2019-01-31 | 170 | 0 |
| K122199 | PREXION3D ECLIPSE | The Yoshida Dental Mfg. Co., Ltd. | 2013-04-18 | 268 | 0 |
| K120948 | PREXION 3D | The Yoshida Dental Mfg. Co., Ltd. | 2012-12-21 | 267 | 0 |
| K120932 | OPELASER PRO II AND THE OPELASER LITE II | The Yoshida Dental Mfg. Co., Ltd. | 2012-12-07 | 254 | 0 |
| K111231 | PANOURA 18S | The Yoshida Dental Mfg. Co., Ltd. | 2011-07-13 | 72 | 0 |
| K063622 | FINECUBE DENTAL CT | The Yoshida Dental Mfg. Co., Ltd. | 2007-02-08 | 65 | 0 |
| K000577 | YOSHIDA WAVE PICT CAM INTRAORAL CAMERA, SIGMA BIOMEDICS SIGM | The Yoshida Dental Mfg. Co., Ltd. | 2000-05-05 | 73 | 0 |
| K837491 | REX PEDESTAL INTRA-ORAL X-RAY UNIT | The Yoshida Dental Mfg. Co., Ltd. | 1983-06-13 | 74 | 0 |
| K828325 | YOSHIDA/KAYCOR X-70 X-RAY UNIT | The Yoshida Dental Mfg. Co., Ltd. | 1982-10-21 | 23 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda