FDA 510(k) Application Details - K961910

Device Classification Name Cement, Dental

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510(K) Number K961910
Device Name Cement, Dental
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 872.3275

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Classification Product Code EMA
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Date Received 05/17/1996
Decision Date 06/26/1996
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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