FDA 510(k) Application Details - K040952

Device Classification Name Agent, Tooth Bonding, Resin

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510(K) Number K040952
Device Name Agent, Tooth Bonding, Resin
Applicant DANVILLE MATERIALS, INC.
2021 OMEGA DR.
SAN RAMON, CA 94583 US
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Contact CRAIG BURNS
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Regulation Number 872.3200

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Classification Product Code KLE
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Date Received 04/12/2004
Decision Date 06/29/2004
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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