FDA 510(k) Application Details - K961434

Device Classification Name Material, Tooth Shade, Resin

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510(K) Number K961434
Device Name Material, Tooth Shade, Resin
Applicant VIDENT
3150 EAST BIRCH ST.
BREA, CA 92821 US
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Contact RAY E MORROW
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Regulation Number 872.3690

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Classification Product Code EBF
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Date Received 04/15/1996
Decision Date 07/08/1996
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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