FDA 510(k) Application Details - K993173

Device Classification Name Alloy, Gold-Based Noble Metal

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510(K) Number K993173
Device Name Alloy, Gold-Based Noble Metal
Applicant JENERIC/PENTRON, INC.
53 NORTH PLAINS INDUSTRIAL RD.
P.O. BOX 724
WALLINGFORD, CT 06492-0724 US
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Contact ANNMARIE TENERO
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Regulation Number 872.3060

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Classification Product Code EJT
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Date Received 09/22/1999
Decision Date 10/26/1999
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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