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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 K150968
Device Name TRU Dental Implant System
Applicant
Sterngold Dental, LLC
23 Frank Mossberg Dr.
Attleboro,  MA  02703
Applicant Contact Maria Rao
Correspondent
Sterngold Dental, LLC
23 Frank Mossberg Dr.
Attleboro,  MA  02703
Correspondent Contact Maria Rao
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/13/2015
Decision Date 07/24/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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