ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4— 510(k) K050255

Name: FDA 510(k) clearance K050255
Creator: U.S. Food and Drug Administration
Published: 2005-03-17

Substantially Equivalent

Gendex Dental Systems

FDA 510(k) clearance K050255 for ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4, Substantially Equivalent on 2005-03-17. Applicant: Gendex Dental Systems. Device class: 2.

Clearance details

Applicant: Gendex Dental Systems
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2005-02-03
Decision date: 2005-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, IL, US

Download summary PDF View on FDA.gov ↗

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