Dental material, glazing/hardening

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Disponible depuis:

American Orthodontics Aust/NZ Pty Ltd

classe:

Class IIa

Fabriqué par:

American Orthodontics Corp 3524 Washington Avenue, Sheboygan, WI, 53081 United States Of America

Domaine thérapeutique:

34771 - Dental material, glazing/hardening

indications thérapeutiques:

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.

Statut de autorisation:

A

Date de l'autorisation:

2019-09-03