REIGNING REPAIR EPOXY RESIN— 510(k) K802491

Substantially Equivalent

Oki Shiks USA , Ltd.

FDA 510(k) clearance K802491 for REIGNING REPAIR EPOXY RESIN, Substantially Equivalent on 1980-11-12. Applicant: Oki Shiks USA , Ltd..

Clearance details

Applicant: Oki Shiks USA , Ltd.
Product code: Code EBI
Advisory panel: Dental
Date received: 1980-10-10
Decision date: 1980-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code EBI

product code EBI

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.