FDA 510(k) Application Details - K032321

Device Classification Name Alloy, Gold-Based Noble Metal

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510(K) Number K032321
Device Name Alloy, Gold-Based Noble Metal
Applicant DENTSPLY INTERNATIONAL
570 WEST COLLEGE AVE.
P.O. BOX 872
YORK, PA 17405-0872 US
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Contact P. JEFFERY LEHN
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Regulation Number 872.3060

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Classification Product Code EJT
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Date Received 07/28/2003
Decision Date 09/30/2003
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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