FDA 510(k) Application Details - K071260

Device Classification Name Agent, Tooth Bonding, Resin

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510(K) Number K071260
Device Name Agent, Tooth Bonding, Resin
Applicant 3M ESPE AG DENTAL PRODUCTS
ESPE PLATZ
SEEFELD, BAVARIA D-82229 DE
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Contact DESI W SOEGIARTO
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Regulation Number 872.3200

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Classification Product Code KLE
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Date Received 05/07/2007
Decision Date 07/17/2007
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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