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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 K111798
Device Name STERNIC IMPLANT 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM, 12.0MM / 4.1MM RN, 1.8MM, 14.0MM ...
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  
Subsequent Product Code
NHA  
Date Received06/27/2011
Decision Date 06/01/2012
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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