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FDA 510(k) Application Details - K070646
Device Classification Name
Agent, Tooth Bonding, Resin
More FDA Info for this Device
510(K) Number
K070646
Device Name
Agent, Tooth Bonding, Resin
Applicant
IVOCLAR VIVADENT, INC.
175 PINEVIEW DR.
AMHERST, NY 14228 US
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Contact
DONNA M HARTNETT
Other 510(k) Applications for this Contact
Regulation Number
872.3200
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Classification Product Code
KLE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/08/2007
Decision Date
05/11/2007
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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