Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Numedical Pty Ltd - Dental rubber dam, non-latex
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.
Cranberry M Sdn Bhd
Lot 85 Jalan Portland Tasek Industrial Estate
Ipoh Perak, , 31400
1. Dental rubber dam, non-latex
Single Device Product
45004 Dental rubber dam, non-latex
Rubber Dam Non-latex; A sheet of elastomeric synthetic material (e.g., silicone) that is punched with holes
and placed over the teeth during dental procedures. It can have a variety of functions such as: 1) to isolate
the field of operation from the rest of the oral cavity; 2) to eliminate saliva; 3) to prevent the patient
swallowing liquid/dental material; 4) to protect soft tissue from harmful solutions; and 5) to reduce risk of
infection. This device may be used for patients and/or staff that have an allergy to latex. This is a
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 12:59:27 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