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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name implant, endosseous, root-form
510(k) Number K122519
Device Name DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM
Original Applicant
DIO CORPORATION
3540 wilshire blvd.
suite 1104
los angeles,  CA  90010
Original Contact timothy lee
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received08/17/2012
Decision Date 05/21/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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