Pre-Milled Blank— 510(k) K193425

Name: FDA 510(k) clearance K193425
Creator: U.S. Food and Drug Administration
Published: 2020-03-09

Substantially Equivalent

Arum Dentistry Co., Ltd.

FDA 510(k) clearance K193425 for Pre-Milled Blank, Substantially Equivalent on 2020-03-09. Applicant: Arum Dentistry Co., Ltd.. Device class: 2.

Clearance details

Applicant: Arum Dentistry Co., Ltd.
Product code: Code NHA
Device class: Class 2
Regulation: 21 CFR 872.3630
Advisory panel: Dental
Date received: 2019-12-10
Decision date: 2020-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yuseong-Gu, Daejeon, KR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NHA

product code NHA

Injury: 1,270
Malfunction: 2,860
Total: 4,130

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.