ALL-CERAMIC ZIRCONIA BLOCK— 510(k) K141162

Name: FDA 510(k) clearance K141162
Creator: U.S. Food and Drug Administration
Published: 2014-08-27

Substantially Equivalent

Rizhao Huge Dental Industry Co., Ltd.

FDA 510(k) clearance K141162 for ALL-CERAMIC ZIRCONIA BLOCK, Substantially Equivalent on 2014-08-27. Applicant: Rizhao Huge Dental Industry Co., Ltd.. Device class: 2.

Clearance details

Applicant: Rizhao Huge Dental Industry Co., Ltd.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2014-05-05
Decision date: 2014-08-27
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Wenzhou, Zhejiang, CN

Download summary PDF View on FDA.gov ↗

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