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510(k) Data Aggregation
Manufacturer
Date Cleared
2025-11-06
(92 days)
Product Code
Regulation Number
872.3200Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
MAGNABOND SE
- Bonding agent for direct restorations of all classes of cavities using light-curing composite or compomer filling materials
- Bonding agent for core build-ups that are made with light-curing composites
MAGNABOND UNIVERSAL
- Bonding agent for direct restorations of all classes of cavities using light-curing composite or compomer filling materials
- Bonding agent for core build-ups that are made of light-curing composites
- Bonding agent for intraoral repair of composite or compomers restorations, porcelain fused to metal (PFM), ceramic veneers and all-ceramic restorations without an additional primer
- Sealing of cavities prior to amalgam restorations
- Sealing of cavities and core preparations prior to the temporary luting of indirect restorations
- Treatment of hypersensitive teeth
- Protective varnish for glass ionomer cement restorations
COMBINED WITH MAGNABOND UNIVERSAL DCA:
- Bonding agent for direct restorations of all classes of cavities using self or dual curing composites and core build-ups
- Bonding agent for indirect restorations using self or dual curing luting composites/cements
- Luting of root posts using self or dual curing luting composites/cements
Device Description
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AI/ML Overview
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