Screw

Main information

  • Trade name:
  • Screw endosteal dental implant, two-piece
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Screw endosteal dental implant, two-piece
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218998
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218998

DIO Australia Pty Ltd - Screw endosteal dental implant, two-piece

ARTG entry for

Medical Device Included Class IIb

Sponsor

DIO Australia Pty Ltd

Postal Address

Level 11 / 33 York Street,SYDNEY, NSW, 2000

Australia

ARTG Start Date

8/01/2014

Product category

Medical Device Class IIb

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

DIO Corporation

66 Centum seo-ro Haeundae-gu Busan

612-020

Korea - Republic of

Products

1. Screw endosteal dental implant, two-piece

Product Type

Medical device system

Effective date

8/01/2014

GMDN

55849 Screw endosteal dental implant, two-piece

Intended purpose

DIO UF HSA Fixture components is indicated for surgical placement in the upper and lower jaw arches, to

provide a root form means for single or multiple units` prosthetic attachment to restore a patient`s chewing

function. The smaller(ø3.8 ~ ø5.5) fixtures can be placed with a conventional two stage surgical process

with an option for transmucosal healing or they can be placed in a single stage surgical process for

immediate loading when good primary stability is achieved with appropriate occlusal loading. The

larger(ø6.0 ~ ø7.0) fixtures can be placed with a conventional two stage surgical process with an option for

transmucosal healing and are indicated for the molar region with delayed loading.

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 08:47:07 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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