Device Dossier
Dental material, glazing/hardening
Device Dossier for Dental material, glazing/hardening (Dental material, glazing/hardening, Class IIa, sponsor American Orthodontics Aust/NZ). ARTG…
- GMDN category: Dental material, glazing/hardening
Intended purpose
A non-sterile, resin-based dental material intended for professional use as a sealant, coating, and/or glazing material during dental restoration (e.g., pit/fissure sealing and/or restorative composite resin sealing/coating), whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of an unfilled resin; it does not include any significant inorganic filler materials and is therefore not classed as a composite resin. It may be preloaded into an applicator. After application, this device cannot be reused.