FDA applicant
Oki Shiks USA, Ltd.
FDA records 9 decisions for Oki Shiks USA, Ltd. (Mchenry, IL) from 1980 to 1982: 9 510(k) clearances. Most are in product codes EBI (Resin, Denture, Relining, Repairing, Rebasing) and ELM (Denture, Plastic, Teeth). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Oki Shiks USA, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Oki Shiks USA, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Oki Shiks USA, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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