Bite

Main information

  • Trade name:
  • Bite block
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Bite block
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221711
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221711

Australian Linen Supply T/A Confident Care Products - Bite block

ARTG entry for

Medical Device Included Class 1

Sponsor

Australian Linen Supply T/A Confident Care Products

Postal Address

PO Box 420,INGLEBURN, NSW, 1890

Australia

ARTG Start Date

26/03/2014

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

Specialized Care Company

206 Woodland Road

Hampton, NH, 03842-1542

United States Of America

Products

1. Bite block

Product Type

Single Device Product

Effective date

26/03/2014

GMDN

10405 Bite block

Intended purpose

Intended to be used to allow easier access through the mouth to allow visualisation and access for tooth

and mouth cleaning. This prevents the patient from biting on the cleaning tool.

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 04:19:28 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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