Cleared Traditional

Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)

K223253 · Arum Dentistry Co., Ltd. · Dental

Feb 2023

Decision

129d

Days

Class 2

Risk

About This 510(k) Submission

K223253 is an FDA 510(k) clearance for the Non-Sterile Zirconia Block (ARENA Star, Mont Blanc), a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Arum Dentistry Co., Ltd. (Daejeon, KR). The FDA issued a Cleared decision on February 27, 2023, 129 days after receiving the submission on October 21, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number	K223253 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 21, 2022
Decision Date	February 27, 2023
Days to Decision	129 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF