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FDA 510(k) Application Details - K093708
Device Classification Name
Crown And Bridge, Temporary, Resin
More FDA Info for this Device
510(K) Number
K093708
Device Name
Crown And Bridge, Temporary, Resin
Applicant
IVOCLAR VIVADENT, INC.
175 PINEVIEW DR.
AMHERST, NY 14228 US
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Contact
DONNA MHARTNETT
Other 510(k) Applications for this Contact
Regulation Number
872.3770
More FDA Info for this Regulation Number
Classification Product Code
EBG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/02/2009
Decision Date
03/10/2010
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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