Matrix

Main information

  • Trade name:
  • Matrix band tensioner, removable
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Matrix band tensioner, removable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218969
  • Last update:
  • 09-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218969

Dentsply Sirona Pty Ltd - Matrix band tensioner, removable

ARTG entry for

Medical Device Included Class 1

Sponsor

Dentsply Sirona Pty Ltd

Postal Address

19 / 39 Herbert Street,St Leonards, NSW, 2065

Australia

ARTG Start Date

7/01/2014

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

Dentsply NZ Ltd

11 Marshall Road

, Katikati, 3166

New Zealand

Products

1. Matrix band tensioner, removable

Product Type

Single Device Product

Effective date

7/01/2014

GMDN

45008 Matrix band tensioner, removable

Intended purpose

An aid to assist dentists with tooth separation and matrix positioning during a class II restoration of

pre-molars and molars

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 08:53:11 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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Scientific recommendation on classification of advanced therapy medicinal products: Extracellular matrix isolated from adipose tissue

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Europe - EMA - European Medicines Agency

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Opinion/decision on a Paediatric investigation plan (PIP): Spherox,spheroids of human autologous matrix-associated chondrocytes, decision type: , therapeutic area: , PIP number: P/0161/2018

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Electronic submissions

Electronic submissions

Update of the eCTD document matrix v2.0 to v2.1 is effective from today

Therapeutic Goods Administration - Australia