Scanning dental implant abutment

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

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Available from:
AIPC Dental Laboratory
Class:
Class 1
Authorization status:
Included
Authorization number:
321461

Public Summary

Summary for ARTG Entry:

321461

AIPC Dental Laboratory - Scanning dental implant abutment

ARTG entry for

Medical Device Included Class 1

Sponsor

AIPC Dental Laboratory

Postal Address

Unit10 / 8 Avenue of the Americas,Newington, NSW, 2127

Australia

ARTG Start Date

8/08/2019

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

DOOWONID Co Ltd

1-dong 44 Techno 8-ro

Yuseong-gu, Daejeon,

Korea - Republic of

Products

1. Scanning dental implant abutment

Product Type

Single Device Product

Effective date

8/08/2019

GMDN

61641 Scanning dental implant abutment

Intended purpose

This device is designed to be used as temporary copy of a dental abutment in a patient to confirm the

position of the final dental fixture during restorative procedures. It is used during a scanning procedure

consisted of a rod-like device intended to be attached to a fixture.

Specific Conditions

© 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 02.11.2019 at 07:38:12 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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