Non-Sterile Zirconia Block— 510(k) K190112

Name: FDA 510(k) clearance K190112
Creator: U.S. Food and Drug Administration
Published: 2019-12-20

Substantially Equivalent

Fine Advanced Compound Co., Ltd.

FDA 510(k) clearance K190112 for Non-Sterile Zirconia Block, Substantially Equivalent on 2019-12-20. Applicant: Fine Advanced Compound Co., Ltd.. Device class: 2.

Clearance details

Applicant: Fine Advanced Compound Co., Ltd.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2019-01-23
Decision date: 2019-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pyeongtaek, KR

Download summary PDF View on FDA.gov ↗

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