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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 K130408
Device Name ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT
Applicant
STERNGOLD DENTAL LLC
23 FRANK MOSSBERG DRIVE
ATTLEBORO,  MA  02703
Applicant Contact MARIA RAO
Correspondent
STERNGOLD DENTAL LLC
23 FRANK MOSSBERG DRIVE
ATTLEBORO,  MA  02703
Correspondent Contact MARIA RAO
Regulation Number872.3630
Classification Product Code
NHA  
Date Received02/19/2013
Decision Date 07/01/2013
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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