Dental material, glazing/hardening

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
American Orthodontics Aust/NZ Pty Ltd
Class IIa
Authorization status:
Authorization number:

Public Summary

Summary for ARTG Entry:


American Orthodontics Aust/NZ Pty Ltd - Dental material, glazing/hardening

ARTG entry for

Medical Device Included Class IIa


American Orthodontics Aust/NZ Pty Ltd

Postal Address

Suite 101/63 Stead Street,SOUTH MELBOURNE, VIC, 3205


ARTG Start Date


Product category

Medical Device Class IIa



Approval area

Medical Devices


- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.




American Orthodontics Corp

3524 Washington Avenue

Sheboygan, WI, 53081

United States Of America


1. Dental material, glazing/hardening

Product Type

Single Device Product

Effective date



34771 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.

Specific Conditions

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at

Public Summary

Page 1 of

Produced at 02.11.2019 at 05:19:06 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

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