Denture

Main information

  • Trade name:
  • Denture base resin kit, self-cured
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Denture base resin kit, self-cured
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218619
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218619

AB Orthodontics Pty Ltd - Denture base resin kit, self-cured

ARTG entry for

Medical Device Included Class 1

Sponsor

AB Orthodontics Pty Ltd

Postal Address

Level 13 / 5 Collins Street,MELBOURNE, VIC, 3000

Australia

ARTG Start Date

17/12/2013

Product category

Medical Device Class 1

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

Leone SPA

50-50019 Sesto

, Fiorentino (FI),

Italy

Products

1. Denture base resin kit, self-cured

Product Type

Procedure Pack

Effective date

17/12/2013

GMDN

55831 Denture base resin kit, self-cured

Intended purpose

Intended to be used in the dental laboratory to manufacture a complete or partial removable denture base

(the portion of a denture that rests on the oral mucosa and retains the artificial teeth).

Specific Conditions

No Specific Conditions included on Record

© 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 10.11.2017 at 09:51:30 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