Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl— 510(k) K170873

Name: FDA 510(k) clearance K170873
Creator: U.S. Food and Drug Administration
Published: 2017-10-02

Substantially Equivalent

Swissmeditec GmbH

FDA 510(k) clearance K170873 for Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl, Substantially Equivalent on 2017-10-02. Applicant: Swissmeditec GmbH. Device class: 2.

Clearance details

Applicant: Swissmeditec GmbH
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2017-03-23
Decision date: 2017-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Finsterwald, CH

Download summary PDF View on FDA.gov ↗

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