AIDITE ZIRCONIA DENTAL CERAMICS— 510(k) K111291

Name: FDA 510(k) clearance K111291
Creator: U.S. Food and Drug Administration
Published: 2011-07-20

Substantially Equivalent

Qinhuangdao Aidite High-Technical Ceramics Co, Ltd.

FDA 510(k) clearance K111291 for AIDITE ZIRCONIA DENTAL CERAMICS, Substantially Equivalent on 2011-07-20. Applicant: Qinhuangdao Aidite High-Technical Ceramics Co, Ltd.. Device class: 2.

Clearance details

Applicant: Qinhuangdao Aidite High-Technical Ceramics Co, Ltd.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2011-05-06
Decision date: 2011-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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