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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 K153509
Device Name GPS Angled Abutment
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 RENEE BENNETT
Regulation Number872.3630
Classification Product Code
NHA  
Date Received12/07/2015
Decision Date 08/26/2016
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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