Non-Sterile Zirconia Block— 510(k) K201492

Substantially Equivalent

Bioden Co., Ltd.

FDA 510(k) clearance K201492 for Non-Sterile Zirconia Block, Substantially Equivalent on 2021-03-10. Applicant: Bioden Co., Ltd.. Device class: 2.

Clearance details

Applicant: Bioden Co., Ltd.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2020-06-04
Decision date: 2021-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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