Manual

Main information

  • Trade name:
  • Manual dental scaler, reusable
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Manual dental scaler, reusable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218453
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218453

Disposable Medical Supplies Pty Ltd - Manual dental scaler, reusable

ARTG entry for

Medical Device Included Class 1

Sponsor

Disposable Medical Supplies Pty Ltd

Postal Address

PO Box 8617,PERTH BC, WA, 6849

Australia

ARTG Start Date

12/12/2013

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

Disposable Medical Supplies Pty Ltd

Unit 3 / 267 Rokeby Road

SUBIACO, WA, 6008

Australia

Products

1. Manual dental scaler, reusable

Product Type

Single Device Product

Effective date

12/12/2013

GMDN

35320 Manual dental scaler, reusable

Intended purpose

To be used in dentistry for removing calculus and other accretions from the surface of teeth during dental

cleaning and periodontal therapy.

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 10:23:02 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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