FDA 510(k) Application Details - K944945

Device Classification Name Liner, Cavity, Calcium Hydroxide

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510(K) Number K944945
Device Name Liner, Cavity, Calcium Hydroxide
Applicant PULPDENT CORP.
80 OAKLAND ST.
P.O. BOX 780
WATERTOWN, MA US
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Contact KENNETH J BERK
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Regulation Number 872.3250

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Classification Product Code EJK
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Date Received 10/07/1994
Decision Date 11/30/1994
Decision SE - Substantially Equivalent
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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