Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Psp Dental Co., Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
254 daysmedian FDA review time
272 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K853089 | SUPER ALGIN, ALGINAMINE, EMPRESS DUSTFREE | Psp Dental Co., Ltd. | 1986-04-21 | 272 | 0 |
| K853094 | EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA | Psp Dental Co., Ltd. | 1986-04-04 | 255 | 0 |
| K853092 | PSP C & B TEMP | Psp Dental Co., Ltd. | 1986-04-03 | 254 | 0 |
| K853091 | CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE | Psp Dental Co., Ltd. | 1986-01-21 | 182 | 0 |
| K853090 | CERAMCHEM, CERAMFIL B, STRATICEM, FLURICEM, FLORIO | Psp Dental Co., Ltd. | 1986-01-21 | 182 | 0 |
| K853093 | PSP TEMP - TRAY | Psp Dental Co., Ltd. | 1985-09-06 | 45 | 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