FDA 510(k) Application Details - K123638

Device Classification Name Crown And Bridge, Temporary, Resin

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510(K) Number K123638
Device Name Crown And Bridge, Temporary, Resin
Applicant CENDRES & METAUX SA
RUE DE BOUJEAN 122
BIEL/BIENNE 2501 CH
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Contact T. BONGNI
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Regulation Number 872.3770

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Classification Product Code EBG
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Date Received 11/26/2012
Decision Date 02/21/2013
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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