FDA 510(k) Application Details - K070956

Device Classification Name Agent, Tooth Bonding, Resin

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510(K) Number K070956
Device Name Agent, Tooth Bonding, Resin
Applicant 3M ESPE DENTAL PRODUCTS
3M CENTER; BLDG 260-2A-11
ST. PAUL, MN 55144-1000 US
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Contact KAREN O'MALLEY
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Regulation Number 872.3200

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Classification Product Code KLE
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Date Received 04/05/2007
Decision Date 05/22/2007
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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