Rubber dam kit

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

Buy It Now

Available from:
Ivoclar Vivadent Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
339314

Public Summary

Summary for ARTG Entry:

339314

Ivoclar Vivadent Pty Ltd - Rubber dam kit

ARTG entry for

Medical Device Included Class 1

Sponsor

Ivoclar Vivadent Pty Ltd

Postal Address

PO Box 367, NOBLE PARK, VIC, 3174

Australia

ARTG Start Date

10/07/2020

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

Nova Instruments

Unit 14 Space Business Centre Molly Millars

Lane Wokingham

, Berkshire, RG41 2PQ

United Kingdom

Products

1 . Rubber dam kit

Product Type

Procedure Pack

Effective Date

10/07/2020

GMDN

45000 Rubber dam kit

Intended Purpose

A collection of devices used to apply and remove a rubber dam, which is created chairside and placed over the crown of a patient's

tooth or teeth in order to eliminate saliva or to prevent the patient swallowing liquid/dental material during dental surgery. It typically

consists of rubber dam material, clamps, forceps, punch, frame, and tray. This is a reusable 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 22.07.2020 at 09:56:38 AEST

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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