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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 K030007
Device Name ITI DENTAL IMPLANT SYSTEM
Original Applicant
STRAUMANN USA
reservoir place,
1601 trapelo road
waltham,  MA  02154
Original Contact linda jalbert
Regulation Number872.3640
Classification Product Code
DZE  
Date Received01/01/2003
Decision Date 03/31/2003
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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