ICE ZIRKON TRANSLUZENT— 510(k) K132230

Substantially Equivalent

Zirkonzahn Srl

FDA 510(k) clearance K132230 for ICE ZIRKON TRANSLUZENT, Substantially Equivalent on 2014-11-05. Applicant: Zirkonzahn Srl. Device class: 2.

Clearance details

Applicant: Zirkonzahn Srl
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2013-07-18
Decision date: 2014-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Silver Creek, NY, 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.