Denture

Main information

  • Trade name:
  • Denture base resin, thermoplastic
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Denture base resin, thermoplastic
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222135
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222135

Ultimate Dental Supplies - Denture base resin, thermoplastic

ARTG entry for

Medical Device Included Class IIa

Sponsor

Ultimate Dental Supplies

Postal Address

660A South Road,MOORABBIN, VIC, 3189

Australia

ARTG Start Date

8/04/2014

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

Megadental GmbH

Seeweg 20

Budingen, , 63654

Germany

Products

1. Denture base resin, thermoplastic

Product Type

Single Device Product

Effective date

8/04/2014

GMDN

58288 Denture base resin, thermoplastic

Intended purpose

This is a resin based acrylic that can be hot, cold or light cured that is intended to be used to manufacture

a temporary, partial, or small to medium size full removable denture base. The material is fabricated as

required for the dental procedure.

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 09.11.2017 at 10:40:10 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