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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 K113497
Device Name HYPERION
Original Applicant
CEFLA S.C. CEFLA DENTAL GROUP
via bicocca n.14/c
imola,  IT b040026
Original Contact marisa testa
Regulation Number872.1800
Classification Product Code
MUH  
Subsequent Product Code
MQB  
Date Received11/25/2011
Decision Date 01/17/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
statement statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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