FDA 510(k) Application Details - K123826

Device Classification Name Cement, Dental

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510(K) Number K123826
Device Name Cement, Dental
Applicant DFL INDUSTRIA E COMERCIO S.A.
18851 NE 29TH AVE 720
AVENTURE, FL 33180 US
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Contact TARA CONRAD
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Regulation Number 872.3275

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Classification Product Code EMA
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Date Received 12/12/2012
Decision Date 02/14/2013
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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