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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 K161281
Device Name Dentalis Bio Solution Implants
Applicant
Dentalis Bio Solution Implants, LLC
2801 Fortune Circle E, Suite B
Indianapolis,  IN  46241
Applicant Contact Osnat Yanai
Correspondent
Dentalis Bio Solution Implants, LLC
2801 Fortune Circle E, Suite B
Indianapolis,  IN  46241
Correspondent Contact Jacob Azulay
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received05/06/2016
Decision Date 01/11/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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