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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 K012757
Device Name ITI DENTAL IMPLANT SYSTEM
Applicant
Straumann USA
Reservoir Place,
1601 Trapelo Rd.
Waltham,  MA  02154
Applicant Contact LINDA JALBERT
Correspondent
Straumann USA
Reservoir Place,
1601 Trapelo Rd.
Waltham,  MA  02154
Correspondent Contact LINDA JALBERT
Regulation Number872.3640
Classification Product Code
DZE  
Date Received08/17/2001
Decision Date 08/22/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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