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FDA 510(k) Application Details - K073697
Device Classification Name
Adhesive, Bracket And Tooth Conditioner, Resin
More FDA Info for this Device
510(K) Number
K073697
Device Name
Adhesive, Bracket And Tooth Conditioner, Resin
Applicant
3M UNITEK
2724 SOUTH PECK RD.
MONROVIA, CA 91016 US
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Contact
L. MARLYN SCHEFF
Other 510(k) Applications for this Contact
Regulation Number
872.3750
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Classification Product Code
DYH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/31/2007
Decision Date
02/15/2008
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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