(90 days)
GRADIA CORE consists of the two articles, GRADIA CORE cartridge and GRADIA CORE self-etching bond. GRADIA CORE cartridge is a two-paste (base and catalyst) type, dual-cured composite resin filled in double syringe to provide auto-mixing system. GRADIA CORE self-etching bond is a two-liquid (A and B), dual-cured self-etching bonding agent to be used for bonding of GRADIA CORE cartridge to the prepared tooth. GRADIA CORE is intended to be used for restoration, core build-up and post cementation.
GRADIA CORE consists of the two articles, GRADIA CORE cartridge and GRADIA CORE self-etching bond. GRADIA CORE cartridge is a two-paste (base and catalyst) type, dual-cured composite resin filled in double syringe to provide auto-mixing system. GRADIA CORE self-etching bond is a two-liquid (A and B), dual-cured self-etching bonding agent to be used for bonding of GRADIA CORE cartridge to the prepared tooth.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA letter regarding a 510(k) premarket notification for a dental device called "GRADIA CORE," confirming its substantial equivalence to legally marketed predicate devices. It discusses regulatory compliance and general information but does not include any performance study data or acceptance criteria.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.