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FDA 510(k) Application Details - K090933
Device Classification Name
Bracket, Ceramic, Orthodontic
More FDA Info for this Device
510(K) Number
K090933
Device Name
Bracket, Ceramic, Orthodontic
Applicant
FORESTADENT BERNHARD FORSTER GMBH
WESTLICHE KARL-FRIEDRICH STR
151
PFORZHEIM, BADEN WURTEMBERG D-75172 DE
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Contact
MICHAEL FIEB
Other 510(k) Applications for this Contact
Regulation Number
872.5470
More FDA Info for this Regulation Number
Classification Product Code
NJM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/02/2009
Decision Date
06/05/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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