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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 K926305
Device Name IMPLA-MED HEX SCREW IMPLANTS: 4,5 & 6MM DIAMETER
Applicant
The Stern Metals Co., Inc.
23 Frank Mossberg Dr.
Attleboro,  MA  02703
Applicant Contact WALTON JR
Correspondent
The Stern Metals Co., Inc.
23 Frank Mossberg Dr.
Attleboro,  MA  02703
Correspondent Contact WALTON JR
Regulation Number872.3640
Classification Product Code
DZE  
Date Received12/15/1992
Decision Date 03/01/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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