FDA 510(k) Application Details - K993013

Device Classification Name Agent, Tooth Bonding, Resin

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510(K) Number K993013
Device Name Agent, Tooth Bonding, Resin
Applicant MIRADENT DISTRIBUTING CO., LLC.
764 SPEEWELL AVE., SUITE 4
MORRIS PLAINS, NJ 07950 US
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Contact BERNARD SESSMAN
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Regulation Number 872.3200

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Classification Product Code KLE
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Date Received 09/07/1999
Decision Date 11/29/1999
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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