SOPIX INSIDE, SOPIX2 INSIDE— 510(k) K140013

Name: FDA 510(k) clearance K140013
Creator: U.S. Food and Drug Administration
Published: 2014-09-05

Substantially Equivalent

Sopro - Acteon Group

FDA 510(k) clearance K140013 for SOPIX INSIDE, SOPIX2 INSIDE, Substantially Equivalent on 2014-09-05. Applicant: Sopro - Acteon Group. Device class: 2.

Clearance details

Applicant: Sopro - Acteon Group
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2014-01-02
Decision date: 2014-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mt Laurel, NJ, US

Download summary PDF View on FDA.gov ↗

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