FDA 510(k) Application Details - K962747

Device Classification Name Cement, Dental

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510(K) Number K962747
Device Name Cement, Dental
Applicant PULPDENT CORP.
80 OAKLAND ST.
P.O. BOX 780
WATERTOWN, MA 02471-0780 US
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Contact KENNETH J BERK
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Regulation Number 872.3275

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Classification Product Code EMA
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Date Received 07/15/1996
Decision Date 09/30/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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