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FDA 510(k) Application Details - K992727
Device Classification Name
Resin, Root Canal Filling
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510(K) Number
K992727
Device Name
Resin, Root Canal Filling
Applicant
MDS
55 NORTHERN BLVD., SUITE 200
NEW YORK, NY 11021 US
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Contact
SUSAN D GOLDSTEIN-FALK
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Regulation Number
872.3820
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Classification Product Code
KIF
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More FDA Info for this Product Code
Date Received
08/13/1999
Decision Date
01/18/2000
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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