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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 K133791
FOIA Releasable 510(k) K133791
Device Name ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S]
Applicant
STERNGOLD DENTAL LLC
23 FRANK MOSSBERG DRIVE
ATTLEBORO,  MA  02703 -0967
Applicant Contact MARIA RAO
Correspondent
STERNGOLD DENTAL LLC
23 FRANK MOSSBERG DRIVE
ATTLEBORO,  MA  02703 -0967
Correspondent Contact MARIA RAO
Regulation Number872.3630
Classification Product Code
NHA  
Date Received12/13/2013
Decision Date 04/16/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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