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FDA 510(k) Application Details - K964174
Device Classification Name
Resin, Root Canal Filling
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510(K) Number
K964174
Device Name
Resin, Root Canal Filling
Applicant
TULSA DENTAL PRODUCTS, LTD.
8309 BRYANT DR.
BETHESDA, MD 20817 US
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Contact
H. N. DUNNING
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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
10/18/1996
Decision Date
02/10/1997
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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