FDA 510(k) Application Details - K120213

Device Classification Name Agent, Tooth Bonding, Resin

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510(K) Number K120213
Device Name Agent, Tooth Bonding, Resin
Applicant PULPDENT CORPORATION
80 Oakland St
WATERTOWN, MA 02472 US
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Contact KENNETH J BERK
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Regulation Number 872.3200

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Classification Product Code KLE
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Date Received 01/24/2012
Decision Date 03/30/2012
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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