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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 K943720
Device Name ITI TRANSVERSAL SCREWING SYSTEM
Applicant
The Straumann Co.
One Alewife Center
Cambridge,  MA  02140
Applicant Contact CAROLYN BITETTI
Correspondent
The Straumann Co.
One Alewife Center
Cambridge,  MA  02140
Correspondent Contact CAROLYN BITETTI
Regulation Number872.3640
Classification Product Code
DZE  
Date Received08/01/1994
Decision Date 03/24/1995
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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