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 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
WILLIAM SAMMONS |
Regulation Number | 872.1800
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/25/2011 |
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
|
|
|