FDA 510(k) Application Details - K073395

Device Classification Name Cement, Dental

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510(K) Number K073395
Device Name Cement, Dental
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 872.3275

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Classification Product Code EMA
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Date Received 12/03/2007
Decision Date 01/17/2008
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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