Denture base resin, cured

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

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Available from:
Roland DG Australia Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
291270

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Public Summary

Summary for ARTG Entry:

291270

Roland DG Australia Pty Ltd - Denture base resin, cured

ARTG entry for

Medical Device Included Class 1

Sponsor

Roland DG Australia Pty Ltd

Postal Address

Allambie Grove Business Park Unit 14/25 Frenchs Forest Road,FRENCHS FOREST, NSW, 2086

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

Vertex Dental BV

3700 AA Zeist

Zeist, Zeist, 0

Netherlands

Products

1. Denture base resin, cured

Product Type

Single Device Product

Effective date

10/07/2017

GMDN

16730 Denture base resin, cured

Intended purpose

SR100-TR is a monomer based on Acrylic esters for manufacturing of 3D-printed individually impression

trays. Suitable for printing all types of dental individual trays. SR100-TR can be used in combination with

all laser and DLP based 3D printers which support SR100-TR material

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 01:02:23 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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