Dental ceramic

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

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Available from:
Provident Dental Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
290110

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Public Summary

Summary for ARTG Entry:

290110

Provident Dental Pty Ltd - Dental ceramic

ARTG entry for

Medical Device Included Class IIa

Sponsor

Provident Dental Pty Ltd

Postal Address

20 Albatross Road,Nowra, NSW, 2541

Australia

ARTG Start Date

13/06/2017

Product category

Medical Device Class IIa

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

Chengdu Besmile Biotechnology Co Ltd

No 1666 Chenglong Road Section two

Economic- technical Development Zone

Chengdu, Sichuan, 610100

China

Products

1. Dental ceramic

Product Type

Single Device Product

Effective date

13/06/2017

GMDN

16187 Dental ceramic

Intended purpose

Disks and blocks for the preparation of full contour (full anatomical)Crowns, bridges, inlays and on

lays(posterior), and can be used for veneers (Anterior).These discs and blocks and used in conjunction

with machines requiring stains, shades and glazes to conclude in direct full ceramic dental restorations.

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 05:00:11 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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