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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 K933193
Device Name IMPLA-MED UCLA TYPE ABUTMENTS,SCREWDRIVER,REAMER,L
Applicant
The Stern Metals Co., Inc.
23 Frank Mossberg Dr.
Attleboro,  MA  02703
Applicant Contact RAYMOND WALTON
Correspondent
The Stern Metals Co., Inc.
23 Frank Mossberg Dr.
Attleboro,  MA  02703
Correspondent Contact RAYMOND WALTON
Regulation Number872.3640
Classification Product Code
DZE  
Date Received06/30/1993
Decision Date 03/07/1994
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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