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FDA 510(k) Application Details - K962456
Device Classification Name
Denture, Plastic, Teeth
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510(K) Number
K962456
Device Name
Denture, Plastic, Teeth
Applicant
IVOCLAR NORTH AMERICA, INC.
175 PINEVIEW DR.
AMHERST, NY 14228 US
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Contact
PETER P MANCUSO
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Regulation Number
872.3590
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Classification Product Code
ELM
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More FDA Info for this Product Code
Date Received
06/25/1996
Decision Date
08/06/1996
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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