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FDA 510(k) Application Details - K964735
Device Classification Name
Agent, Tooth Bonding, Resin
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510(K) Number
K964735
Device Name
Agent, Tooth Bonding, Resin
Applicant
CENTRIX, INC.
770 RIVER RD.
SHELTON, CT 06484-5458 US
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Contact
JOHN DISCKO
Other 510(k) Applications for this Contact
Regulation Number
872.3200
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Classification Product Code
KLE
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More FDA Info for this Product Code
Date Received
11/25/1996
Decision Date
02/05/1997
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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