K Number
K251778Device Name
Remi Custom Night GuardManufacturer
Date Cleared
2025-10-17
(129 days)
Product Code
Regulation Number
N/AType
TraditionalPanel
DentalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Loading...
N/A