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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
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