FDA 510(k) Application Details - K093446

Device Classification Name Powder, Porcelain

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510(K) Number K093446
Device Name Powder, Porcelain
Applicant VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG.
3150 EAST BIRCH ST.
BREA, CA 92821 US
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Contact ELIZABETH WOLFSEN
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Regulation Number 872.6660

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Classification Product Code EIH
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Date Received 11/05/2009
Decision Date 12/03/2009
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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