FDA · official record K150823Substantially Equivalent

EDLENi Intra-Oral Sensor

Name: EDLENi Intra-Oral Sensor — FDA K150823
Creator: Edlen Imaging, LLC
Keywords: EDLENi Intra-Oral Sensor, EDLENi Intra-Oral Sensor, K150823, MUH, FDA

United StatesMUHEdlen Imaging, LLC

Verified

Official record identity

FDA application number: K150823
Decision date: August 26, 2015
Published decision: Substantially Equivalent

Classification

Product code: MUH

Published parties

Applicant: Edlen Imaging, LLC

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Abbreviated
Received date: 2015-03-27
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.