Screw

Main information

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

Documents

Localization

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

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221389
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221389

JRZ Technologies Pty Ltd - Screw endosteal dental implant, one-piece

ARTG entry for

Medical Device Included Class IIb

Sponsor

JRZ Technologies Pty Ltd

Postal Address

PO Box 1011,EPPING, NSW, 1710

Australia

ARTG Start Date

18/03/2014

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

Adin Dental Implant Systems Ltd

Industrial Zone

Alon Tavor

Afula POB 1128, Afula, 18550

Israel

Products

1. Screw endosteal dental implant, one-piece

Product Type

Single Device Product

Effective date

18/03/2014

GMDN

55848 Screw endosteal dental implant, one-piece

Intended purpose

These are devices that are intended to be surgically implanted into alveolar or basal bone of the mandible

or the maxilla to provide the support for a dental prosthesis.

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 01:14:38 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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The chairs may have missing screws or washers, loose screws or inadequate spot welding, resulting in potential collapse of the chair and injury to the user.

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