Dio Corporation: FDA clearances and approvals
Dio Corporation has 14 FDA 510(k) clearances (first 2010, latest 2023), across 3 product codes in 1 review panel. Median 510(k) review time: 232 days. Since 2017 its median was 217 days, against 181 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 277 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 217 |
| 2018 | 4 | 200 |
| 2019 | 1 | 263 |
| 2020 | 3 | 184 |
| 2021 | 1 | 4 |
| 2022 | 0 | — |
| 2023 | 1 | 564 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Dio Corporation's cleared 510(k)s took a median 217 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 181 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 7 | 7 |
| NHA | Abutment, Implant, Dental, Endosseous | 5 | 5 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | 2 |
Review panels
- Dental (14)
Most recent Dio Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220253 | Eco Abutment, Multiunit Abutment | NHA | 2023-08-18 | 564 |
| K210828 | DIOnavi-Denture02 | EBI | 2021-03-23 | 4 |
| K193623 | DIOnavi-Denture | EBI | 2020-10-22 | 301 |
| K193404 | UF(II) Bar holder abutment | NHA | 2020-05-18 | 164 |
| K192263 | UCLA CCM Abutment | NHA | 2020-02-21 | 184 |
| K190048 | UF(II) Anatomic abutment | NHA | 2019-09-30 | 263 |
| K181037 | DIO CAD/CAM Abutment | NHA | 2018-12-21 | 246 |
| K182194 | UV Active Implant System | DZE | 2018-12-14 | 122 |
| K173975 | UF(II) Wide Fixture | DZE | 2018-06-01 | 154 |
| K170608 | UF(II) Implant System | DZE | 2018-03-30 | 394 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dio Corporation.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Dio Corporation have?
Dio Corporation has 14 FDA 510(k) clearances (first 2010, latest 2023), across 3 product codes in 1 review panel.
How long does FDA take to clear Dio Corporation's 510(k)s?
The median time from FDA receipt to decision across Dio Corporation's cleared 510(k)s is 232 days. Since 2017: 217 days, versus 181 days for all cleared 510(k)s in the same product codes.
What devices does Dio Corporation make?
Its most frequent FDA product codes are DZE (Implant, Endosseous, Root-Form, 7); NHA (Abutment, Implant, Dental, Endosseous, 5); EBI (Resin, Denture, Relining, Repairing, Rebasing, 2).
Has Dio Corporation had device recalls?
openFDA lists no recalls under a recalling firm name matching Dio Corporation. Related entities may recall under other names.
Next steps
- See all 14 Dio Corporation clearances with predicates and recalls
- Run predicate analysis for product code DZE, Dio Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.