Dental rubber dam, non-latex

Australia - English - Department of Health (Therapeutic Goods Administration)

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Numedical Pty Ltd
Class 1
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Public Summary

Summary for ARTG Entry:


Numedical Pty Ltd - Dental rubber dam, non-latex

ARTG entry for

Medical Device Included Class 1


Numedical Pty Ltd

Postal Address

9-13 Hender Avenue,Magil, SA, 5072


ARTG Start Date


Product category

Medical Device Class 1



Approval area

Medical Devices


- 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

Product Type

Single Device Product

Effective date



45004 Dental rubber dam, non-latex

Intended purpose

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

single-use device.

Specific Conditions

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

Public Summary

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.

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