Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dio Corporation — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
246 daysmedian FDA review time
394 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220253 | Eco Abutment, Multiunit Abutment | Dio Corporation | 2023-08-18 | 564 | 0 |
| K210828 | DIOnavi-Denture02 | Dio Corporation | 2021-03-23 | 4 | 0 |
| K193623 | DIOnavi-Denture | Dio Corporation | 2020-10-22 | 301 | 0 |
| K193404 | UF(II) Bar holder abutment | Dio Corporation | 2020-05-18 | 164 | 0 |
| K192263 | UCLA CCM Abutment | Dio Corporation | 2020-02-21 | 184 | 0 |
| K190048 | UF(II) Anatomic abutment | Dio Corporation | 2019-09-30 | 263 | 0 |
| K181037 | DIO CAD/CAM Abutment | Dio Corporation | 2018-12-21 | 246 | 0 |
| K182194 | UV Active Implant System | Dio Corporation | 2018-12-14 | 122 | 0 |
| K173975 | UF(II) Wide Fixture | Dio Corporation | 2018-06-01 | 154 | 0 |
| K170608 | UF(II) Implant System | Dio Corporation | 2018-03-30 | 394 | 0 |
| K161987 | UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implan | Dio Corporation | 2017-02-21 | 217 | 0 |
| K122519 | DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM | Dio Corporation | 2013-05-21 | 277 | 0 |
| K112746 | DIOSLIMON IMPLANT SYSTEM | Dio Corporation | 2011-10-21 | 30 | 0 |
| K100100 | DIO STEADY EXTERNAL IMPLANT SYSTEM | Dio Corporation | 2010-11-10 | 302 | 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