Occlusal

Main information

  • Trade name:
  • Occlusal splint, dental,
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Occlusal splint, dental,
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218365
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218365

Dental Imagination Pty Ltd - Occlusal splint, dental, <specify>

ARTG entry for

Medical Device Included Class 1

Sponsor

Dental Imagination Pty Ltd

Postal Address

GPO Box 3733,SYDNEY, NSW, 2001

Australia

ARTG Start Date

11/12/2013

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

Plastyle GmbH

Lessingstrasse 5

Uttenreuth, , 91080

Germany

Products

1. Occlusal splint, dental, <specify>

Product Type

Single Device Product

Effective date

11/12/2013

GMDN

44360 Occlusal splint, dental, <specify>

Intended purpose

This is a flexible appliance that is intended to overlay the occlusal surfaces of the teeth. It is used to

maintain the position of displaced or movable teeth, to treat clenching and bruxism and their sequelae, and

to provide temporary relief from muscle or temporo-mandibular joint (TMJ) conditions.

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 10:44:14 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