a2c67d5b-c1ed-4a7c-9af5-f16727edacadNewPublished12024-07-312024-07-23In Commercial DistributionD87097972PrimaryHIBCCEasyGum Strip97979797794668751Harvest Dental Products, LLC1EasyGum™ Strip LC Comp Starter KitfalsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK23138900035870Dental 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.falseActiveEBIResin, Denture, Relining, Repairing, Rebasingfalsefalse