Abrasive

Main information

  • Trade name:
  • Abrasive strip, dental
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Abrasive strip, dental
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220100
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220100

Ssoma Pty Ltd T/a CPC Creative Products - Abrasive strip, dental

ARTG entry for

Medical Device Included Class 1

Sponsor

Ssoma Pty Ltd T/a CPC Creative Products

Postal Address

PO Box 596,MARLESTON DC, SA, 5033

Australia

ARTG Start Date

13/02/2014

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

Intensiv SA

Via al Molino

Grancia, Grancia, CH-6916

Switzerland

Products

1. Abrasive strip, dental

Product Type

Single Device Product

Effective date

13/02/2014

GMDN

35702 Abrasive strip, dental

Intended purpose

Manual metal dental strips coated with diamond particles on one or both sides used for modifying the

surface of a tooth or restoration, for opening of tight contact points between teeth or for removal of coronal

excess of adhesive aesthetic restoration.

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 04:32:06 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