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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 K132814
Device Name SFI-BAR IMPLANT ABUTMENTS
Applicant
Sterngold Dental, LLC
23 Frank Mossberg Dr.
Attleboro,  MA  02703 -0967
Applicant Contact MARIA RAO
Correspondent
Sterngold Dental, LLC
23 Frank Mossberg Dr.
Attleboro,  MA  02703 -0967
Correspondent Contact MARIA RAO
Regulation Number872.3630
Classification Product Code
NHA  
Date Received09/09/2013
Decision Date 02/25/2014
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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