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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 K013798
Device Name PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM
Applicant
INSTITUT STRAUMANN AG
RESERVOIR PLACE
1601 TRAPELO ROAD
WALTHAM,  MA  02451
Applicant Contact LINDA JALBERT
Correspondent
INSTITUT STRAUMANN AG
RESERVOIR PLACE
1601 TRAPELO ROAD
WALTHAM,  MA  02451
Correspondent Contact LINDA JALBERT
Regulation Number872.3640
Classification Product Code
DZE  
Date Received11/15/2001
Decision Date 12/19/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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