Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Numedical Pty Ltd - Dental material mixing nozzle, non-sterile
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 material mixing nozzle, non-sterile
Single Device Product
58399 Dental material mixing nozzle, non-sterile
Dental material mixing nozzle, non-sterile; A non-sterile device designed for mixing inactive compounds
during a dental procedure to produce a functional dental restorative/impression material which may be
applied directly to the oral cavity/teeth of the patient or used for some other dental application. It is
nozzle-shaped and has an integral mixing mechanism (e.g., spiral channels). It is attached to the end of a
cartridge consisting of two tubes so that the compounds are mixed as they are expressed simultaneously
from the tubes through the nozzle. This is a single-use device.
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.
Page 1 of
Produced at 03.11.2017 at 01:44:55 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