Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)— 510(k) K223253

Name: FDA 510(k) clearance K223253
Creator: U.S. Food and Drug Administration
Published: 2023-02-27

Substantially Equivalent

Arum Dentistry Co., Ltd.

FDA 510(k) clearance K223253 for Non-Sterile Zirconia Block (ARENA Star, Mont Blanc), Substantially Equivalent on 2023-02-27. Applicant: Arum Dentistry Co., Ltd.. Device class: 2.

Clearance details

Applicant: Arum Dentistry Co., Ltd.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2022-10-21
Decision date: 2023-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daejeon, KR

Download summary PDF View on FDA.gov ↗

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K262195 — Dandy Ceramic Stain and Glaze2026-06-30
K260918 — Zolid Lunaris2026-06-29

More clearances from Arum Dentistry Co., Ltd.

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K242245 — Customized Abutment2024-11-25

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