Summary for ARTG Entry:
One Dental Pty Ltd - Dental material, root filling, gutta-percha
ARTG entry for
Medical Device Included Class IIa
One Dental Pty Ltd
Unit 8 /9 Packard Avenue,CASTLE HILL, NSW, 2154
ARTG Start Date
Medical Device Class IIa
- 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.
Sure Dent Corporation
809 Suntech-city 11 307-2 Sangdaewon-dong
Jungwon-gu, Seongnam-si, 462-806
Korea - Republic of
1. Dental material, root filling, gutta-percha
Single Device Product
31872 Dental material, root filling, gutta-percha
A device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The
gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 10:09:55 AEDT
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