U.S. Shizai Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “U.S. Shizai Corp.” (first 1980, latest 1986), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 32 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 |
|---|---|---|---|
| EJS | Alloy, Other Noble Metal | 1 | 1 |
| EKA | File, Margin Finishing, Operative | 1 | 1 |
| EKM | Gutta-Percha | 1 | 1 |
| ELC | Scaler, Ultrasonic | 1 | 1 |
| ELW | Material, Impression | 1 | 1 |
Review panels
- Dental (5)
Most recent U.S. Shizai Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K853841 | HARMO SONIC | ELC | 1986-02-04 | 141 |
| K822464 | OBTURATION GUTTA | EKA | 1982-11-03 | 79 |
| K820639 | OBTURATION SYSTEM KIT | EKM | 1982-04-09 | 32 |
| K802189 | DENTLOID | ELW | 1980-09-26 | 16 |
| K800951 | CASTA-LLOY | EJS | 1980-05-08 | 15 |
Recalls
openFDA lists no recalls under a recalling firm named U.S. Shizai Corp..
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 U.S. Shizai Corp.?
FDA lists 5 510(k) clearances under the applicant name “U.S. Shizai Corp.” (first 1980, 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 U.S. Shizai Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name U.S. Shizai Corp. is 32 days.
Which FDA product codes appear under U.S. Shizai Corp.?
The most frequent FDA product codes under this applicant name are EJS (Alloy, Other Noble Metal, 1); EKA (File, Margin Finishing, Operative, 1); EKM (Gutta-Percha, 1).
Next steps
- See all 5 U.S. Shizai Corp. clearances with predicates and recalls
- Run predicate analysis for product code EJS, U.S. Shizai Corp.'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.