Dental rubber dam, non-latex

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

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Available from:
Numedical Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
291280

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Public Summary

Summary for ARTG Entry:

291280

Numedical Pty Ltd - Dental rubber dam, non-latex

ARTG entry for

Medical Device Included Class 1

Sponsor

Numedical Pty Ltd

Postal Address

9-13 Hender Avenue,Magil, SA, 5072

Australia

ARTG Start Date

10/07/2017

Product category

Medical Device Class 1

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

Cranberry M Sdn Bhd

Lot 85 Jalan Portland Tasek Industrial Estate

Ipoh Perak, , 31400

Malaysia

Products

1. Dental rubber dam, non-latex

Product Type

Single Device Product

Effective date

10/07/2017

GMDN

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 http://www.tga.gov.au/about/website-copyright.htm.

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.

Visit www.tga.gov.au for contact information

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