FDA 510(k) Application Details - K023742

Device Classification Name Material, Tooth Shade, Resin

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510(K) Number K023742
Device Name Material, Tooth Shade, Resin
Applicant PENTRON LABORATORY TECHNOLOGIES
53 NORTH PLAINS INDUSTRIAL RD.
WALLINGFORD, CT 06492-0724 US
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Contact ANNMARIE TENERO
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Regulation Number 872.3690

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Classification Product Code EBF
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Date Received 11/07/2002
Decision Date 01/17/2003
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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