Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Numedical Pty Ltd - Dental wedge, single-use
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 wedge, single-use
Single Device Product
45007 Dental wedge, single-use
Dental wedge, single-use; A dental device that is positioned wedge-like at the interdental and cervical area
of the teeth during routine intraoral dental procedures. It is used to slightly separate the teeth during the
placement of a filling material, or to stabilize and support other devices, e.g., a matrix band or a rubber
dam. This is a single-use device.
No Specific Conditions included on Record
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Produced at 03.11.2017 at 01:30:27 AEDT
This is not an ARTG Certificate document.
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