Oki Shiks USA , Ltd.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Oki Shiks USA , Ltd.” (first 1980, latest 1982), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 33 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 |
|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 4 | 4 |
| ELM | Denture, Plastic, Teeth | 2 | 2 |
| EBF | Material, Tooth Shade, Resin | 1 | 1 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EMA | Cement, Dental | 1 | 1 |
Review panels
- Dental (9)
Most recent Oki Shiks USA , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K821217 | REIGNING DENTURE | EBI | 1982-06-07 | 41 |
| K802490 | REIGNING DENTURE | EBI | 1980-11-19 | 40 |
| K802492 | REIGNING ARTIFICIAL TEETH | ELM | 1980-11-12 | 33 |
| K802491 | REIGNING REPAIR EPOXY RESIN | EBI | 1980-11-12 | 33 |
| K802489 | REIGNING CROWN BRIDGE | EBG | 1980-11-12 | 33 |
| K801236 | REIGNING EPOXY RESIN CEMENT | EMA | 1980-07-08 | 42 |
| K801235 | REIGNING ARTIFICIAL TEETH/POLYCARB.RESIN | ELM | 1980-06-20 | 24 |
| K801237 | REIGNING CROWN-BRIDGE/POLYCARB. RESIN | EBF | 1980-06-09 | 13 |
| K801234 | REIGNING DENTURE MADE OF POLYCARB. RESIN | EBI | 1980-06-09 | 13 |
Recalls
openFDA lists no recalls under a recalling firm named Oki Shiks USA , 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 Oki Shiks USA , Ltd.?
FDA lists 9 510(k) clearances under the applicant name “Oki Shiks USA , Ltd.” (first 1980, latest 1982), 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 Oki Shiks USA , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Oki Shiks USA , Ltd. is 33 days.
Which FDA product codes appear under Oki Shiks USA , Ltd.?
The most frequent FDA product codes under this applicant name are EBI (Resin, Denture, Relining, Repairing, Rebasing, 4); ELM (Denture, Plastic, Teeth, 2); EBF (Material, Tooth Shade, Resin, 1).
Next steps
- See all 9 Oki Shiks USA , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EBI, Oki Shiks USA , 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.