CERAMILL ZI— 510(k) K063511

Substantially Equivalent

Amann Girrbach America, Inc.

FDA 510(k) clearance K063511 for CERAMILL ZI, Substantially Equivalent on 2007-02-02. Applicant: Amann Girrbach America, Inc.. Device class: 2.

Clearance details

Applicant: Amann Girrbach America, Inc.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2006-11-20
Decision date: 2007-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, IL, 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.