FDA 510(k) Application Details - K091632

Device Classification Name Sealant, Pit And Fissure, And Conditioner

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510(K) Number K091632
Device Name Sealant, Pit And Fissure, And Conditioner
Applicant 3M COMPANY
3M CENTER,BLDG. 275-2W-08
ST. PAUL, MN 55144-1000 US
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Contact SHARI MYSZKA
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Regulation Number 872.3765

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Classification Product Code EBC
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Date Received 06/04/2009
Decision Date 09/03/2009
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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