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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 STR
151
PFORZHEIM, BADEN WURTEMBERG,  DE D-75172
Applicant Contact MICHAEL FIEB
Correspondent
FORESTADENT BERNHARD FORSTER GMBH
WESTLICHE KARL-FRIEDRICH STR
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
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