Denture base resin, thermoplastic

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

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Available from:
Numedical Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
291283

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Public Summary

Summary for ARTG Entry:

291283

Numedical Pty Ltd - Denture base resin, thermoplastic

ARTG entry for

Medical Device Included Class 1

Sponsor

Numedical Pty Ltd

Postal Address

9-13 Hender Avenue,Magil, SA, 5072

Australia

ARTG Start Date

10/07/2017

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

BH Medical Products Co Ltd

No90 Shenjiang Villagers' Group

Zhangjiacunwei Xilin Street Zhonglou District

Changzhou City, Jiangsu Province,

China

Products

1. Denture base resin, thermoplastic

Product Type

Single Device Product

Effective date

10/07/2017

GMDN

58288 Denture base resin, thermoplastic

Intended purpose

Denture base resin, thermoplastic; A thermoplastic material intended to be used in the dental laboratory to

manufacture a temporary, partial, or fully-removable denture base (the portion of a denture that rests on

the oral mucosa and retains the artificial teeth); it may also be used to manufacture occlusal splints and

night guards. The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank] is

manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the

shape needed for the patient. After application, this device cannot be reused.

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 03.11.2017 at 12:58:40 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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