Retraction

Main information

  • Trade name:
  • Retraction kit, gingival
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Retraction kit, gingival
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221562
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221562

Adam Dental Supplies - Retraction kit, gingival

ARTG entry for

Medical Device Included Class 1

Sponsor

Adam Dental Supplies

Postal Address

80/66 Kingsway Parade,GLEN WAVERLEY, VIC, 3150

Australia

ARTG Start Date

22/03/2014

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

Dentland

109-B Production Technology Institute

Yeungnam University 214-1 Dae-dong

Kyungsan-si, Kyungsang-do,

Korea - Republic of

Products

1. Retraction kit, gingival

Product Type

Single Device Product

Effective date

22/03/2014

GMDN

16352 Retraction kit, gingival

Intended purpose

A thick paste to hold off the gingiva during abutment preparation. Gently retracts the soft tissue in 2

minutes and then is rinsed away with air and water prior to taking a dental impression.

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 10.11.2017 at 12:40:14 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