FDA 510(k) Application Details - K120779

Device Classification Name Crown And Bridge, Temporary, Resin

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510(K) Number K120779
Device Name Crown And Bridge, Temporary, Resin
Applicant VOCO GMBH
ANTON-FLETTNER-STRASSE 1-3
CUXHAVEN D-27472 DE
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Contact T. GERKENSMEIER
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Regulation Number 872.3770

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Classification Product Code EBG
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Date Received 03/14/2012
Decision Date 06/01/2012
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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