FDA 510(k) Application Details - K102254

Device Classification Name Agent, Tooth Bonding, Resin

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510(K) Number K102254
Device Name Agent, Tooth Bonding, Resin
Applicant DMP LTD
KALYVION AVENUE
MARKOPOULO INDUSTRIAL ZONE
MARKOPOULO, ATTIKI 19003 GR
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Contact DIMITRIS PRANTSIDIS
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Regulation Number 872.3200

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Classification Product Code KLE
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Date Received 08/10/2010
Decision Date 11/23/2010
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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