FDA 510(k) Application Details - K041960

Device Classification Name Agent, Tooth Bonding, Resin

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510(K) Number K041960
Device Name Agent, Tooth Bonding, Resin
Applicant DMG USA, INC.
414 SOUTH STATE ST.
DOVER, DE 19901 US
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Contact PAMELA PAPINEAU
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Regulation Number 872.3200

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Classification Product Code KLE
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Date Received 07/21/2004
Decision Date 08/30/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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