FDA 510(k) Application Details - K994304

Device Classification Name Material, Tooth Shade, Resin

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510(K) Number K994304
Device Name Material, Tooth Shade, Resin
Applicant VOCO GMBH
7527 WESTMORELAND AVE.
ST. LOUIS, MO 63105 US
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Contact EVAN DICK
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Regulation Number 872.3690

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Classification Product Code EBF
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Date Received 12/21/1999
Decision Date 02/07/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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