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FDA 510(k) Application Details - K120619
Device Classification Name
Adhesive, Bracket And Tooth Conditioner, Resin
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510(K) Number
K120619
Device Name
Adhesive, Bracket And Tooth Conditioner, Resin
Applicant
NOVOCOL, INC.
416 S Taylor Ave
LOUISVILLE, CO 80027 US
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Contact
STEVE RUDOLPH
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Regulation Number
872.3750
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Classification Product Code
DYH
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More FDA Info for this Product Code
Date Received
02/29/2012
Decision Date
05/21/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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