FDA 510(k) Application Details - K971622

Device Classification Name Resin, Root Canal Filling

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510(K) Number K971622
Device Name Resin, Root Canal Filling
Applicant MPL TECHNOLOGIES, INC.
9400 KING ST.
FRANKLIN PARK, IL 60131 US
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Contact DANIEL J OSTERBY
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Regulation Number 872.3820

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Classification Product Code KIF
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Date Received 05/02/1997
Decision Date 06/20/1997
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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