Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Oki Shiks USA , Ltd. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
33 daysmedian FDA review time
42 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K821217 | REIGNING DENTURE | Oki Shiks USA , Ltd. | 1982-06-07 | 41 | 0 |
| K802490 | REIGNING DENTURE | Oki Shiks USA , Ltd. | 1980-11-19 | 40 | 0 |
| K802492 | REIGNING ARTIFICIAL TEETH | Oki Shiks USA , Ltd. | 1980-11-12 | 33 | 0 |
| K802491 | REIGNING REPAIR EPOXY RESIN | Oki Shiks USA , Ltd. | 1980-11-12 | 33 | 0 |
| K802489 | REIGNING CROWN BRIDGE | Oki Shiks USA , Ltd. | 1980-11-12 | 33 | 0 |
| K801236 | REIGNING EPOXY RESIN CEMENT | Oki Shiks USA , Ltd. | 1980-07-08 | 42 | 0 |
| K801235 | REIGNING ARTIFICIAL TEETH/POLYCARB.RESIN | Oki Shiks USA , Ltd. | 1980-06-20 | 24 | 0 |
| K801237 | REIGNING CROWN-BRIDGE/POLYCARB. RESIN | Oki Shiks USA , Ltd. | 1980-06-09 | 13 | 0 |
| K801234 | REIGNING DENTURE MADE OF POLYCARB. RESIN | Oki Shiks USA , Ltd. | 1980-06-09 | 13 | 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