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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 K120089
Device Name BIOGENESIS IMPLANT SYSTEM
Original Applicant
BIOGENESIS CO., LTD.
1515 east katella avenue
unit 2115
anaheim,  CA  92805
Original Contact priscilla chung
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received01/11/2012
Decision Date 03/13/2013
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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