UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE)— 510(k) K053172

Name: FDA 510(k) clearance K053172
Creator: U.S. Food and Drug Administration
Published: 2006-06-09

Substantially Equivalent

Owandy Sas

FDA 510(k) clearance K053172 for UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE), Substantially Equivalent on 2006-06-09. Applicant: Owandy Sas. Device class: 2.

Clearance details

Applicant: Owandy Sas
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2005-11-14
Decision date: 2006-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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