Dental wedge, single-use

Australia - English - Department of Health (Therapeutic Goods Administration)

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Honour International Trading Pty Ltd
Class 1
Authorization status:
Authorization number:

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Public Summary

Summary for ARTG Entry:


Honour International Trading Pty Ltd - Dental wedge, single-use

ARTG entry for

Medical Device Included Class 1


Honour International Trading Pty Ltd

Postal Address

PO Box 298,BURWOOD, VIC, 3125


ARTG Start Date


Product category

Medical Device Class 1



Approval area

Medical Devices


- 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.




Huanghua Promisee Dental Co Ltd

Mould Industry Garden Empolder Section

Huanghua, Hebei Province, 061100



1. Dental wedge, single-use

Product Type

Single Device Product

Effective date



45007 Dental wedge, single-use

Intended purpose

A dental device that is positioned wedge-like at the interdental and cervical area of the teeth during routine

intraoral dental procedures. It is used to slightly separate the teeth during the placement of a filling

material, or to stabilize and support other devices, e.g., a matrix band/strip, or a rubber dam. This is a

single-use device.

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

Public Summary

Page 1 of

Produced at 03.11.2017 at 01:09:09 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.

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