Flex Fit— 510(k) K190790

Name: FDA 510(k) clearance K190790
Creator: U.S. Food and Drug Administration
Published: 2020-07-31

Substantially Equivalent

Dk Mungyo Corporation

FDA 510(k) clearance K190790 for Flex Fit, Substantially Equivalent on 2020-07-31. Applicant: Dk Mungyo Corporation. Device class: 2.

Clearance details

Applicant: Dk Mungyo Corporation
Product code: Code EBI
Device class: Class 2
Regulation: 21 CFR 872.3760
Advisory panel: Dental
Date received: 2019-03-27
Decision date: 2020-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gimhae-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBI

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K261802 — Glidewell Denture Base Resin2026-08-27
K261626 — UltraPrint Flexible Denture UV2026-08-13
K262681 — NanoCeram Resin2026-07-31
K262300 — Denture Base Resin V22026-07-08
K261474 — DENTCA Tru Flexible2026-07-01

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.