FDA 510(k) Application Details - K990040

Device Classification Name Agent, Tooth Bonding, Resin

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510(K) Number K990040
Device Name Agent, Tooth Bonding, Resin
Applicant KURARAY CO.
200 PARK AVE.
NEW YORK, NY 10166 US
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Contact KOJI FUJITA
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Regulation Number 872.3200

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Classification Product Code KLE
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Date Received 01/06/1999
Decision Date 02/04/1999
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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