PROFIL COMPOSITES (PROFIL, PROFIL FLOW)— 510(k) K103190

Name: FDA 510(k) clearance K103190
Creator: U.S. Food and Drug Administration
Published: 2011-02-02

Substantially Equivalent

Silmet , Ltd.

FDA 510(k) clearance K103190 for PROFIL COMPOSITES (PROFIL, PROFIL FLOW), Substantially Equivalent on 2011-02-02. Applicant: Silmet , Ltd.. Device class: 2.

Clearance details

Applicant: Silmet , Ltd.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2010-10-28
Decision date: 2011-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Or Yehuda, IL

Download summary PDF View on FDA.gov ↗

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