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FDA 510(k) Application Details - K190339
Device Classification Name
Sealant, Pit And Fissure, And Conditioner
More FDA Info for this Device
510(K) Number
K190339
Device Name
Sealant, Pit And Fissure, And Conditioner
Applicant
Ivoclar Vivadent, AG
Bendererstrasse 2
Schaan FL-9494 LI
Other 510(k) Applications for this Company
Contact
Sandra Cakebread
Other 510(k) Applications for this Contact
Regulation Number
872.3765
More FDA Info for this Regulation Number
Classification Product Code
EBC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/14/2019
Decision Date
07/29/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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