FDA 510(k) Application Details - K111431

Device Classification Name Agent, Tooth Bonding, Resin

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510(K) Number K111431
Device Name Agent, Tooth Bonding, Resin
Applicant PENTRON CLINICAL
1717 WEST COLLINS AVENUE
ORANGE, CA 92867 US
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Contact Wendy Garman
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Regulation Number 872.3200

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Classification Product Code KLE
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Date Received 05/23/2011
Decision Date 08/01/2011
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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