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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 K141188
Device Name MICRODENT GENIUS IMPLANT SYSTEM
Applicant
Implant Microdent
144 Research Dr.
Hampton,  VA  23666
Applicant Contact RHONDA ALEXANDER
Correspondent
Implant Microdent
144 Research Dr.
Hampton,  VA  23666
Correspondent Contact RHONDA ALEXANDER
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received05/08/2014
Decision Date 06/02/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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