FDA 510(k) Application Details - K110747

Device Classification Name Crown And Bridge, Temporary, Resin

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510(K) Number K110747
Device Name Crown And Bridge, Temporary, Resin
Applicant KERR CORPORATION
1717 WEST COLLINS AVENUE
ORANGE, CA 92867 US
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Contact Wendy Garman
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Regulation Number 872.3770

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Classification Product Code EBG
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Date Received 03/17/2011
Decision Date 06/14/2011
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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