FDA 510(k) Application Details - K073697

Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin

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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
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Regulation Number 872.3750

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Classification Product Code DYH
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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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