FDA 510(k) Application Details - K033974

Device Classification Name Agent, Tooth Bonding, Resin

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510(K) Number K033974
Device Name Agent, Tooth Bonding, Resin
Applicant 3M ESPE AG DENTAL PRODUCTS
ESPE PLATZ
SEEFELD, BAVARIA D-82229 DE
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Contact ANDREAS PETERMANN
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Regulation Number 872.3200

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Classification Product Code KLE
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Date Received 12/22/2003
Decision Date 02/06/2004
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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