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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 K133206
Device Name Z-RAY INTRA-ORAL DIGITAL RADIOGRAPHY SYSTEM
Applicant
ZUMA DENTAL, LLC
27001 LA PAZ ROAD, STE 312
MISSION VIEJO,  CA  92691
Applicant Contact ALBERT REGO
Correspondent
ZUMA DENTAL, LLC
27001 LA PAZ ROAD, STE 312
MISSION VIEJO,  CA  92691
Correspondent Contact ALBERT REGO
Regulation Number872.1800
Classification Product Code
MUH  
Date Received10/17/2013
Decision Date 05/13/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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