Prettau, ICE, Z-White zirconia blanks— 510(k) K183304

Name: FDA 510(k) clearance K183304
Creator: U.S. Food and Drug Administration
Published: 2019-04-04

Substantially Equivalent

Zirkonzahn Srl

FDA 510(k) clearance K183304 for Prettau, ICE, Z-White zirconia blanks, Substantially Equivalent on 2019-04-04. 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: 2018-11-28
Decision date: 2019-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gais, IT

Download summary PDF View on FDA.gov ↗

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