Device typeDental composite resin: A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.
FDA categoryLINER, CAVITY, CALCIUM HYDROXIDE
Device IDD0026234001
Catalog number623400
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information
Size1 Base (13g), 1 Catalyst (11g), 1 Mixing Pad, 1 Mixing/Placement Instrument
Weight13 Gram
Weight11 Gram