Dental material, glazing/hardening

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

American Orthodontics Aust/NZ Pty Ltd

Class:

Class IIa

Manufactured by:

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

Therapeutic area:

34771 - Dental material, glazing/hardening

Therapeutic indications:

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.

Authorization status:

A

Authorization date:

2019-09-03