Light-cured

Main information

  • Trade name:
  • Light-cured dental restorative composite resin
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Light-cured dental restorative composite resin
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219344
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219344

Vicdent Pty Ltd T/a Vicdent International - Light-cured dental restorative composite resin

ARTG entry for

Medical Device Included Class IIa

Sponsor

Vicdent Pty Ltd T/a Vicdent International

Postal Address

PO Box 2478,TAYLORS LAKES, VIC, 3038

Australia

ARTG Start Date

16/01/2014

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

Itena Clinical

83 Avenue Foch

, Paris, 75116

France

Products

1. Light-cured dental restorative composite resin

Product Type

Single Device Product

Effective date

16/01/2014

GMDN

38764 Light-cured dental restorative composite resin

Intended purpose

This is a dental restorative material consisting of a blend of glass or ceramic particles dispersed in a

synthetic, photo-polymerizable, organic resin matrix that is typically used to fill dental cavitie. It is typically

a single-paste system consisting of a dimethacrylate resin, and either a mixture of bisphenol A and

glycidylmethacrylate (BISGMA) or urethane dimethacrylate (UDEMA); the filler is usually made of glass,

quartz, ceramic, or silica combined with 5-10% weight of very small-sized particles of colloidal silica. This

single-use product should match the colour of the original teeth for aesthetic reasons.

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 02.12.2017 at 04:39:06 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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Human medicines highlights - June 2018

Human medicines highlights - June 2018

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency.

Europe - EMA - European Medicines Agency

9-4-2018

Human medicines highlights - April 2018

Human medicines highlights - April 2018

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency.

Europe - EMA - European Medicines Agency