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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K032498
Device Name DENTAL IMPLANT COPING (PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM)
Applicant
STRAUMANN USA
60 MINUTETEMAN ROAD
ANDOVER,  MA  01810
Applicant Contact LINDA JALBERT
Correspondent
STRAUMANN USA
60 MINUTETEMAN ROAD
ANDOVER,  MA  01810
Correspondent Contact LINDA JALBERT
Regulation Number872.3630
Classification Product Code
NHA  
Date Received08/13/2003
Decision Date 08/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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