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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 K981516
Device Name STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB
Applicant
Sterngold/Implamed
23 Frank Mossberg Dr.
Attleboro,  MA  02703
Applicant Contact KAREN HICKEY
Correspondent
Sterngold/Implamed
23 Frank Mossberg Dr.
Attleboro,  MA  02703
Correspondent Contact KAREN HICKEY
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/28/1998
Decision Date 05/11/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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