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FDA 510(k) Application Details - K080906
Device Classification Name
Bracket, Ceramic, Orthodontic
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
872.5470
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Classification Product Code
NJM
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More FDA Info for this Product Code
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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