FDA · official record K050255Substantially Equivalent

ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4

Name: ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4 — FDA K050255
Creator: Gendex Dental Systems
Keywords: ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4, ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4, K050255, EHD, FDA

United StatesEHDGendex Dental Systems

Verified

Official record identity

FDA application number: K050255
Decision date: March 17, 2005
Published decision: Substantially Equivalent

Classification

Product code: EHD

Published parties

Applicant: Gendex Dental Systems

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2005-02-03
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.1800

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.