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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 K033984
Device Name STRAUMANN DENTAL IMPLANT SYSTEM
Applicant
Institut Straumann AG
Reservoir Pl. 1601 Trapelo Rd.
Waltham,  MA  02451
Applicant Contact LINDA JALBERT
Correspondent
Institut Straumann AG
Reservoir Pl. 1601 Trapelo Rd.
Waltham,  MA  02451
Correspondent Contact LINDA JALBERT
Regulation Number872.3640
Classification Product Code
DZE  
Date Received12/23/2003
Decision Date 06/30/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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