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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 K003271
Device Name MODIFICATION TO ITI DENTAL IMPLANT SYSTEM
Applicant
Institut Straumann AG
Reservoir Pl. 1601 Trapelo Rd.
Waltham,  MA  02451
Applicant Contact CAROLYN BITETTI
Correspondent
Institut Straumann AG
Reservoir Pl. 1601 Trapelo Rd.
Waltham,  MA  02451
Correspondent Contact CAROLYN BITETTI
Regulation Number872.3640
Classification Product Code
DZE  
Date Received10/18/2000
Decision Date 03/20/2001
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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