FDA 510(k) Application Details - K961089

Device Classification Name Point, Silver, Endodontic

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510(K) Number K961089
Device Name Point, Silver, Endodontic
Applicant PULPDENT CORP.
80 OAKLAND ST.
WATERTOWN, MA 02472 US
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Contact KENNETH J BERK
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Regulation Number 872.3840

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Classification Product Code EKL
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Date Received 03/19/1996
Decision Date 04/23/1996
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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