FDA 510(k) Application Details - K070215

Device Classification Name Agent, Tooth Bonding, Resin

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510(K) Number K070215
Device Name Agent, Tooth Bonding, Resin
Applicant TOKUYAMA DENTAL CORPORATION
1425 K STREET, N.W. SUITE 1100
WASHINGTON, DC 20005 US
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Contact ROBERT A SILVERMAN
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Regulation Number 872.3200

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Classification Product Code KLE
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Date Received 01/23/2007
Decision Date 03/30/2007
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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