FDA 510(k) Application Details - K051796

Device Classification Name Agent, Tooth Bonding, Resin

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510(K) Number K051796
Device Name Agent, Tooth Bonding, Resin
Applicant KURARAY MEDICAL KURASHIKI PLANT
101 EAST 52ND STREET
26TH FLOOR
NEW YORK, NY 10022 US
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Contact SATOSHI YAMAGUCHI
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Regulation Number 872.3200

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Classification Product Code KLE
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Date Received 07/05/2005
Decision Date 08/09/2005
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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