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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K181359
Device Name InterActive SMARTBase Abutments
Applicant
Implant Direct Sybron Manufacturing, LLC
3050 E Hillcrest Dr.
Thousand Oaks,  CA  91362
Applicant Contact Reina Choi
Correspondent
Implant Direct Sybron Manufacturing, LLC
3050 E Hillcrest Dr.
Thousand Oaks,  CA  91362
Correspondent Contact Reina Choi
Regulation Number872.3630
Classification Product Code
NHA  
Subsequent Product Code
PNP  
Date Received05/22/2018
Decision Date 08/15/2018
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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