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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 K894844
Device Name BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS
Applicant
Straumann Institute, Ltd.
50 Longwood Ave., Apt. 412
Brookline,  MA  02146
Applicant Contact HANS-PETER WEBER
Correspondent
Straumann Institute, Ltd.
50 Longwood Ave., Apt. 412
Brookline,  MA  02146
Correspondent Contact HANS-PETER WEBER
Regulation Number872.3640
Classification Product Code
DZE  
Date Received07/31/1989
Decision Date 02/02/1990
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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