FDA 510(k) Application Details - K122467

Device Classification Name System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

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510(K) Number K122467
Device Name System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
Applicant 3M COMPANY
2510 CONWAY AVENUE
ST. PAUL, MN 55144 US
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Contact GINGER CANTOR
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Regulation Number 872.3661

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Classification Product Code NOF
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Date Received 08/13/2012
Decision Date 11/20/2012
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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