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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bracket, Ceramic, Orthodontic
510(k) Number K090933
Device Name BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS
Applicant
Forestadent Bernhard Forster GmbH
Westliche Karl-Friedrich St.
151
Pforzheim, Baden Wurtemberg,  DE D-75172
Applicant Contact MICHAEL FIEB
Correspondent
Forestadent Bernhard Forster GmbH
Westliche Karl-Friedrich St.
151
Pforzheim, Baden Wurtemberg,  DE D-75172
Correspondent Contact MICHAEL FIEB
Regulation Number872.5470
Classification Product Code
NJM  
Date Received04/02/2009
Decision Date 06/05/2009
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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