FDA 510(k) Application Details - K080906

Device Classification Name Bracket, Ceramic, Orthodontic

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510(K) Number K080906
Device Name Bracket, Ceramic, Orthodontic
Applicant CDB CORPORATION
9201 INDUSTRIAL BLVD.
LELAND, NC 28451 US
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Contact JENS RUMSFELD
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Regulation Number 872.5470

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Classification Product Code NJM
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Date Received 04/01/2008
Decision Date 10/17/2008
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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