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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
Applicant
Cefla S.C. Cefla Dental Group
Via Bicocca N.14/C
Imola,  IT B040026
Applicant Contact MARISA TESTA
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact WILLIAM SAMMONS
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
Predetermined Change
Control Plan Authorized		 No
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