Artificial

Main information

  • Trade name:
  • Artificial teeth, resin
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Artificial teeth, resin
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217526
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217526

Ultimate Dental Supplies - Artificial teeth, resin

ARTG entry for

Medical Device Included Class 1

Sponsor

Ultimate Dental Supplies

Postal Address

660A South Road,MOORABBIN, VIC, 3189

Australia

ARTG Start Date

20/11/2013

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

Polident DD Dental Products Industry

42 Vocja Draga

, , 5293

Slovenia

Products

1. Artificial teeth, resin

Product Type

Single Device Product

Effective date

20/11/2013

GMDN

38643 Artificial teeth, resin

Intended purpose

These are prefabricated teeth that are intended to be used for mounting on dentures and partial dentures.

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 02:02:42 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

10-10-2018

Tanning booths: ANSES issues a reminder of the proven risk of skin cancer

Tanning booths: ANSES issues a reminder of the proven risk of skin cancer

The health risks associated with exposure to artificial UV radiation from tanning booths have been well established for many years now. ANSES points out that recent data on the subject support previous assessments: there is a proven cancer risk associated with UV radiation from artificial tanning equipment. The Agency therefore recommends that the public authorities take the necessary steps to prevent people from being exposed to artificial UV radiation from tanning booths used for cosmetic purposes.

France - Agence Nationale du Médicament Vétérinaire

11-9-2018

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Published on: Mon, 27 Aug 2018 00:00:00 +0200 EFSA regards the household as a stage in the food chain that is important for the final number of food‐borne infections. The fate of a pathogen in the private kitchen largely depends on consumer hygiene during preparation of food and on its proper cooking, especially in the case of meat. Unfortunately, detailed information on the microbiological survival in meat products after heating in the consumer kitchen is lacking. The aim of the study was to improve th...

Europe - EFSA - European Food Safety Authority Publications

17-8-2018

Temporary Total Artificial Heart Companion 2 Driver System by SynCardia Systems: Letter to Health Care Providers - Risk of Mortality and Stroke

Temporary Total Artificial Heart Companion 2 Driver System by SynCardia Systems: Letter to Health Care Providers - Risk of Mortality and Stroke

FDA has reviewed the final results from the post-approval study conducted by SynCardia Systems, LLC. for their Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System). These final results indicate a higher mortality rate and higher stroke rate for patients initially supported with the C2 Driver System compared to patients initially supported with the previous generation driver, the Circulatory Support System (CSS) Console.

FDA - U.S. Food and Drug Administration

30-5-2018

FDA approves first artificial iris

FDA approves first artificial iris

FDA approves first artificial iris, a surgically implanted device to treat aniridia or other damage to the iris

FDA - U.S. Food and Drug Administration

24-5-2018

FDA permits marketing of artificial intelligence algorithm for aiding providers in detecting wrist fractures

FDA permits marketing of artificial intelligence algorithm for aiding providers in detecting wrist fractures

FDA permits marketing of artificial intelligence algorithm for aiding providers in detecting wrist fractures

FDA - U.S. Food and Drug Administration

There are no news related to this product.