Dental material, root filling, gutta-percha

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

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Available from:
Medi-Dent Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
322648

Public Summary

Summary for ARTG Entry:

322648

Medi-Dent Pty Ltd - Dental material, root filling, gutta-percha

ARTG entry for

Medical Device Included Class IIa

Sponsor

Medi-Dent Pty Ltd

Postal Address

39-41 Lakewood Boulevard,Braeside, VIC, 3195

Australia

ARTG Start Date

4/09/2019

Product category

Medical Device Class IIa

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

Diadent Group International

16 Osongsaengmyeong 4-ro Osong-eup

Heungdeok-gu Cheongju-si

, Chungcheongbuk-do, 28161

Korea - Republic of

Products

1. Dental material, root filling, gutta-percha

Product Type

Single Device Product

Effective date

4/09/2019

GMDN

31872 Dental material, root filling, gutta-percha

Intended purpose

Used for the filling of root canal to prevent re-occurrence of pathologies in root canal which may occur if

root canal is not obturated.

Specific Conditions

© 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 02.11.2019 at 05:13:06 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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