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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scaler, Rotary
510(k) Number K111724
Device Name STRAUMANN TIBRUSH
Applicant
Straumann USA
60 Minuteman Rd.
Andover,  MA  01810
Applicant Contact ELAINE ALAN
Correspondent
Straumann USA
60 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact ELAINE ALAN
Regulation Number872.4840
Classification Product Code
ELB  
Date Received06/20/2011
Decision Date 09/12/2011
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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