Dental ceramic

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

Buy It Now

Available from:
AIPC Dental Laboratory
Class:
Class IIa
Authorization status:
Included
Authorization number:
289855

Read the complete document

Public Summary

Summary for ARTG Entry:

289855

AIPC Dental Laboratory - Dental ceramic

ARTG entry for

Medical Device Included Class IIa

Sponsor

AIPC Dental Laboratory

Postal Address

Unit 2 / 550 Blaxland Road,Eastwood, NSW, 2122

Australia

ARTG Start Date

7/06/2017

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

Acucera Co Ltd

111 Umgogae-gil Naechon-myun Pochon-si

, Gyeonggi-do, 487-835

Korea - Republic of

Products

1. Dental ceramic

Product Type

Single Device Product

Effective date

7/06/2017

GMDN

16187 Dental ceramic

Intended purpose

A ceramic-based material - a ingot of ceramic material - is intended to be used in prefabricated and

custom-made 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 05:44:52 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

Search alerts related to this product

Share this information