ZIBONE ZIRCONIA BLOCKS— 510(k) K140836

Name: FDA 510(k) clearance K140836
Creator: U.S. Food and Drug Administration
Published: 2015-06-17

Substantially Equivalent

Coho Technology Co., Ltd.

FDA 510(k) clearance K140836 for ZIBONE ZIRCONIA BLOCKS, Substantially Equivalent on 2015-06-17. Applicant: Coho Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Coho Technology Co., Ltd.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2014-04-02
Decision date: 2015-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taoyuan County, TW

Download summary PDF View on FDA.gov ↗

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