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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
Applicant
SIMPLER IMPLANT SOLUTIONS
No. 404, 1023 WOLFE AVE
VANCOUVER,  CA V6H1V6
Applicant Contact HAROLD BERGMAN
Correspondent
SIMPLER IMPLANT SOLUTIONS
No. 404, 1023 WOLFE AVE
VANCOUVER,  CA V6H1V6
Correspondent Contact HAROLD BERGMAN
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/30/2012
Decision Date 04/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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