FDA 510(k) Application Details - K022969

Device Classification Name Alloy, Gold-Based Noble Metal

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510(K) Number K022969
Device Name Alloy, Gold-Based Noble Metal
Applicant IVOCLAR VIVADENT, INC.
175 PINEVIEW DR.
AMHERST, NY 14228 US
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Contact ANDERJEET GULATI
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Regulation Number 872.3060

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Classification Product Code EJT
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Date Received 09/06/2002
Decision Date 10/18/2002
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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