DIOnavi-Denture02— 510(k) K210828

Name: FDA 510(k) clearance K210828
Creator: U.S. Food and Drug Administration
Published: 2021-03-23

Substantially Equivalent

Dio Corporation

FDA 510(k) clearance K210828 for DIOnavi-Denture02, Substantially Equivalent on 2021-03-23. Applicant: Dio Corporation. Device class: 2.

Clearance details

Applicant: Dio Corporation
Product code: Code EBI
Device class: Class 2
Regulation: 21 CFR 872.3760
Advisory panel: Dental
Date received: 2021-03-19
Decision date: 2021-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Busan, KR

Download summary PDF View on FDA.gov ↗

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K262681 — NanoCeram Resin2026-07-31
K262300 — Denture Base Resin V22026-07-08
K261474 — DENTCA Tru Flexible2026-07-01

More clearances from Dio Corporation

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K220253 — Eco Abutment, Multiunit Abutment2023-08-18
K193623 — DIOnavi-Denture2020-10-22
K193404 — UF(II) Bar holder abutment2020-05-18
K192263 — UCLA CCM Abutment2020-02-21
K190048 — UF(II) Anatomic abutment2019-09-30

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.