ZERION ALPHA,; ZERION BETA— 510(k) K061804

Name: FDA 510(k) clearance K061804
Creator: U.S. Food and Drug Administration
Published: 2006-10-06

Substantially Equivalent

Etkon International GmbH

FDA 510(k) clearance K061804 for ZERION ALPHA,; ZERION BETA, Substantially Equivalent on 2006-10-06. Applicant: Etkon International GmbH. Device class: 2.

Clearance details

Device name as filed: ZERION ALPHA, ; ZERION BETA
Applicant: Etkon International GmbH
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2006-06-27
Decision date: 2006-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Graefelfing, Bavaria, DE

Download summary PDF View on FDA.gov ↗

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