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FDA 510(k) Application Details - K973667
Device Classification Name
Resin, Root Canal Filling
More FDA Info for this Device
510(K) Number
K973667
Device Name
Resin, Root Canal Filling
Applicant
NEO DENTAL CHEMICAL PRODUCTS CO., LTD.
7613 CARTERET RD.
BETHESDA, MD 20817 US
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Contact
KYLE H SIBINOVIC
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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
09/25/1997
Decision Date
11/06/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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