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FDA 510(k) Application Details - K032625
Device Classification Name
Bracket, Plastic, Orthodontic
More FDA Info for this Device
510(K) Number
K032625
Device Name
Bracket, Plastic, Orthodontic
Applicant
ULTRADENT PRODUCTS, INC.
505 WEST 10200 SOUTH
SOUTH JORDAN, UT 84095 US
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Contact
PETER ALLRED
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
08/26/2003
Decision Date
02/26/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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