7a762850-a514-45e5-b501-78be33ab4a53UpdatePublished32018-07-062016-09-22In Commercial DistributionD7796071A40PrimaryHIBCCRenamelĀ® Microfill6071A46071A4113911689COSMEDENT, INC.1falsefalsefalsefalsefalsefalsetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK85475500035870Dental composite resinA 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.falseActiveEBFMaterial, Tooth Shade, Resinfalsefalse