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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 K991436
Device Name STERNGOLD IMPLAMED NARROW PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTRUMENTATION
Applicant
Sterngold
23 Frank Mossberg Dr.
Attleboro,  MA  02703
Applicant Contact GORDON NELSON
Correspondent
Sterngold
23 Frank Mossberg Dr.
Attleboro,  MA  02703
Correspondent Contact GORDON NELSON
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/26/1999
Decision Date 05/07/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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