FDA 510(k) Application Details - K022973

Device Classification Name Agent, Tooth Bonding, Resin

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510(K) Number K022973
Device Name Agent, Tooth Bonding, Resin
Applicant AB ARDENT
54 RIVERVIEW AVE.
TONAWANDA, NY 14150-5260 US
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Contact CLYDE E INGERSOLL
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Regulation Number 872.3200

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Classification Product Code KLE
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Date Received 09/06/2002
Decision Date 11/22/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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