EDLENi Intra-Oral Sensor— 510(k) K150823

Substantially Equivalent

Edlen Imaging, LLC

FDA 510(k) clearance K150823 for EDLENi Intra-Oral Sensor, Substantially Equivalent on 2015-08-26. Applicant: Edlen Imaging, LLC. Device class: 2.

Clearance details

Applicant: Edlen Imaging, LLC
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2015-03-27
Decision date: 2015-08-26
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Scottsdale, AZ, US

Download summary PDF View on FDA.gov ↗

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