Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Numedical Pty Ltd - Dental impression tray, reusable
ARTG entry for
Medical Device Included Class 1
Numedical Pty Ltd
9-13 Hender Avenue,Magil, SA, 5072
ARTG Start Date
Medical Device Class 1
- 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.
BH Medical Products Co Ltd
No90 Shenjiang Villagers' Group
Zhangjiacunwei Xilin Street Zhonglou District
Changzhou City, Jiangsu Province,
1. Dental impression tray, reusable
Single Device Product
35850 Dental impression tray, reusable
Dental impression tray, reusable; A horseshoe-shaped receptacle made of metal or plastic designed to
carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be
recorded (e.g., teeth and gums), and to control the impression material while it sets to form an impression.
The device is used mainly to facilitate the manufacturing of custom dental prostheses (e.g., dentures). This
is a reusable device.
No Specific Conditions included on Record
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Produced at 03.11.2017 at 01:34:24 AEDT
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