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FDA 510(k) Application Details - K082207
Device Classification Name
Bracket, Plastic, Orthodontic
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510(K) Number
K082207
Device Name
Bracket, Plastic, Orthodontic
Applicant
CADENT, INC.
1700 PENNSYLVANIA AVE NW
WASHINGTON, DC 20006 US
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Contact
LAURIE CLARKE
Other 510(k) Applications for this Contact
Regulation Number
872.5470
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Classification Product Code
DYW
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More FDA Info for this Product Code
Date Received
08/05/2008
Decision Date
10/23/2009
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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