Psp Dental Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Psp Dental Co., Ltd.” (first 1985, latest 1986), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 218 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EMA | Cement, Dental | 2 | 2 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EBH | Material, Impression Tray, Resin | 1 | 1 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 | 1 |
| ELW | Material, Impression | 1 | 1 |
Review panels
- Dental (6)
Most recent Psp Dental Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K853089 | SUPER ALGIN, ALGINAMINE, EMPRESS DUSTFREE | ELW | 1986-04-21 | 272 |
| K853094 | EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA | EBI | 1986-04-04 | 255 |
| K853092 | PSP C & B TEMP | EBG | 1986-04-03 | 254 |
| K853091 | CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE | EMA | 1986-01-21 | 182 |
| K853090 | CERAMCHEM, CERAMFIL B, STRATICEM, FLURICEM, FLORIO | EMA | 1986-01-21 | 182 |
| K853093 | PSP TEMP - TRAY | EBH | 1985-09-06 | 45 |
Recalls
openFDA lists no recalls under a recalling firm named Psp Dental 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 Psp Dental Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Psp Dental Co., Ltd.” (first 1985, latest 1986), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Psp Dental Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Psp Dental Co., Ltd. is 218 days.
Which FDA product codes appear under Psp Dental Co., Ltd.?
The most frequent FDA product codes under this applicant name are EMA (Cement, Dental, 2); EBG (Crown And Bridge, Temporary, Resin, 1); EBH (Material, Impression Tray, Resin, 1).
Next steps
- See all 6 Psp Dental Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EMA, Psp Dental 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.