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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K150823
Device Name EDLENi Intra-Oral Sensor
Applicant
Edlen Imaging, LLC
16441 N. 91st St.
Suite 102
Scottsdale,  AZ  85250
Applicant Contact Nick Radachi
Correspondent
Edlen Imaging, LLC
16441 N. 91st St.
Suite 102
Scottsdale,  AZ  85250
Correspondent Contact Nick Radachi
Regulation Number872.1800
Classification Product Code
MUH  
Date Received03/27/2015
Decision Date 08/26/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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