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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 K143011
Device Name 2014 InterActive/SwishActive System
Applicant
Implant Direct Sybron Manufacturing, LLC
3050 E Hillcrest Dr.
Thousand Oaks,  CA  91362
Applicant Contact Debleena Sinha
Correspondent
Implant Direct Sybron Manufacturing, LLC
3050 E Hillcrest Dr.
Thousand Oaks,  CA  91362
Correspondent Contact Debleena Sinha
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received10/20/2014
Decision Date 07/16/2015
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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