FDA 510(k) Application Details - K121915

Device Classification Name Material, Tooth Shade, Resin

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510(K) Number K121915
Device Name Material, Tooth Shade, 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 872.3690

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Classification Product Code EBF
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Date Received 07/02/2012
Decision Date 09/28/2012
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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