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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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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