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FDA 510(k) Application Details - K994435

Device Classification Name Powder, Porcelain

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510(K) Number K994435
Device Name Powder, Porcelain
Applicant JENERIC/PENTRON, INC.
53 NORTH PLAINS INDUSTRIAL RD.
P.O. BOX 724
WALLINGFORD, CT US
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Contact ANNMARIE TENERO
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Regulation Number 872.6660

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Classification Product Code EIH
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Date Received 12/30/1999
Decision Date 02/10/2000
Decision SE - Substantially Equivalent
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review N



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