FDA 510(k) Application Details - K014144

Device Classification Name Material, Tooth Shade, Resin

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510(K) Number K014144
Device Name Material, Tooth Shade, Resin
Applicant AFP IMAGING CORP.
250 CLEARBROOK RD.
ELMSFORD, NY 10523 US
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Contact DAVID VOZICK
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Regulation Number 872.3690

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Classification Product Code EBF
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Date Received 12/18/2001
Decision Date 02/07/2002
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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