FDA 510(k) Application Details - K051867

Device Classification Name Material, Tooth Shade, Resin

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510(K) Number K051867
Device Name Material, Tooth Shade, Resin
Applicant VOCO GMBH
19379 BLUE LAKE LOOP
BEND, OR 97702 US
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Contact GERALD W SHIPPS
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Regulation Number 872.3690

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Classification Product Code EBF
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Date Received 07/11/2005
Decision Date 07/27/2005
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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