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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 K121281
Device Name SIMPLI SIMPLER IMPLANT SYSTEM
Original Applicant
SIMPLER IMPLANT SOLUTIONS
no. 404, 1023 wolfe ave
vancouver,  CA v6h1v6
Original Contact harold bergman
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/30/2012
Decision Date 04/05/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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