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FDA 510(k) Application Details - K210804
Device Classification Name
Agent, Tooth Bonding, Resin
More FDA Info for this Device
510(K) Number
K210804
Device Name
Agent, Tooth Bonding, Resin
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
872.3200
More FDA Info for this Regulation Number
Classification Product Code
KLE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/17/2021
Decision Date
06/07/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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