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FDA 510(k) Application Details - K232498
Device Classification Name
Sealant, Pit And Fissure, And Conditioner
More FDA Info for this Device
510(K) Number
K232498
Device Name
Sealant, Pit And Fissure, And Conditioner
Applicant
Ultradent Product, Inc.
505 West Ultradent Drive (10200 South)
South Jordan, UT 84095 US
Other 510(k) Applications for this Company
Contact
Ruth Gardner
Other 510(k) Applications for this Contact
Regulation Number
872.3765
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Classification Product Code
EBC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/17/2023
Decision Date
08/18/2023
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
Y
Expedited Review
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