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FDA 510(k) Application Details - K965216
Device Classification Name
Teeth, Porcelain
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510(K) Number
K965216
Device Name
Teeth, Porcelain
Applicant
ARGEN PRECIOUS METALS, INC.
5855 OBERLIN DR.
SAN DIEGO, CA 92121-4718 US
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Contact
PAUL J CASCONE
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Regulation Number
872.3920
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Classification Product Code
ELL
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More FDA Info for this Product Code
Date Received
12/30/1996
Decision Date
02/27/1997
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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