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FDA 510(k) Application Details - K072338
Device Classification Name
Varnish, Cavity
More FDA Info for this Device
510(K) Number
K072338
Device Name
Varnish, Cavity
Applicant
IVOCLAR VIVADENT, INC.
175 PINEVIEW DR.
AMHERST, NY 14228 US
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Contact
DONNA MARIE HARTNETT
Other 510(k) Applications for this Contact
Regulation Number
872.3260
More FDA Info for this Regulation Number
Classification Product Code
LBH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/20/2007
Decision Date
09/21/2007
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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