FDA 510(k) Application Details - K060893

Device Classification Name Material, Tooth Shade, Resin

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510(K) Number K060893
Device Name Material, Tooth Shade, Resin
Applicant VOCO GMBH
ANTON-FLETTNER-STRASSE 1-3
CUXHAVEN D-27472 DE
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Contact MICHAEL SUS
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Regulation Number 872.3690

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Classification Product Code EBF
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Date Received 04/03/2006
Decision Date 05/25/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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