FDA · official record K140281Substantially Equivalent

FLEXI-LUME LED SYSTEM

Name: FLEXI-LUME LED SYSTEM — FDA K140281
Creator: Epic Medical Concepts & Innovations
Keywords: FLEXI-LUME LED SYSTEM, FLEXI-LUME LED SYSTEM, K140281, EBZ, FDA

United StatesEBZEpic Medical Concepts & Innovations

Verified

Official record identity

FDA application number: K140281
Decision date: July 24, 2014
Published decision: Substantially Equivalent

Classification

Product code: EBZ

Published parties

Applicant: Epic Medical Concepts & Innovations

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Abbreviated
Received date: 2014-02-04
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.6070

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.