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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 K033922
Device Name MODIFICATION TO ITI DENTAL IMPLANT SYSTEM
Applicant
INSTITUT STRAUMANN AG
RESERVOIR PLACE
1601 TRAPELO ROAD
WALTHAM,  MA  02451
Applicant Contact CAROLYN BITETTI
Correspondent
INSTITUT STRAUMANN AG
RESERVOIR PLACE
1601 TRAPELO ROAD
WALTHAM,  MA  02451
Correspondent Contact CAROLYN BITETTI
Regulation Number872.3640
Classification Product Code
DZE  
Date Received12/18/2003
Decision Date 01/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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