FDA 510(k) Application Details - K120453

Device Classification Name Material, Tooth Shade, Resin

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510(K) Number K120453
Device Name Material, Tooth Shade, Resin
Applicant 3M ESPE DENTAL PRODUCTS
3M CENTER; BLDG 260-2A-11
ST. PAUL, MN 55144-1000 US
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Contact SCOTT ERICKSON
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Regulation Number 872.3690

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Classification Product Code EBF
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Date Received 02/14/2012
Decision Date 03/19/2012
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 Y
Expedited Review



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