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:
Class IIa
Authorization status:
Included
Authorization number:
322622

Public Summary

Summary for ARTG Entry:

322622

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

ARTG entry for

Medical Device Included Class IIa

Sponsor

American Orthodontics Aust/NZ Pty Ltd

Postal Address

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

Australia

ARTG Start Date

3/09/2019

Product category

Medical Device Class IIa

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

American Orthodontics Corp

3524 Washington Avenue

Sheboygan, WI, 53081

United States Of America

Products

1. Dental material, glazing/hardening

Product Type

Single Device Product

Effective date

3/09/2019

GMDN

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 http://www.tga.gov.au/about/website-copyright.htm.

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.

Visit www.tga.gov.au for contact information

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