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FDA 510(k) Application Details - K081415
Device Classification Name
Bracket, Ceramic, Orthodontic
More FDA Info for this Device
510(K) Number
K081415
Device Name
Bracket, Ceramic, Orthodontic
Applicant
ORMCO CORP.
1717 WEST COLLINS AVENUE
ORANGE, CA 92867 US
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Contact
Wendy Garman
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
05/20/2008
Decision Date
09/24/2008
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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