DIOnavi-Denture— 510(k) K193623

Substantially Equivalent

Dio Corporation

FDA 510(k) clearance K193623 for DIOnavi-Denture, Substantially Equivalent on 2020-10-22. Applicant: Dio Corporation.

Clearance details

Applicant: Dio Corporation
Product code: Code EBI
Advisory panel: Dental
Date received: 2019-12-26
Decision date: 2020-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Busan, KR

Download summary PDF View on FDA.gov ↗

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.