Main information

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



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

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221900
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


AB Orthodontics Pty Ltd - Screw endosteal dental implant, two-piece

ARTG entry for

Medical Device Included Class IIb


AB Orthodontics Pty Ltd

Postal Address

Level 13 / 5 Collins Street,MELBOURNE, VIC, 3000


ARTG Start Date


Product category

Medical Device Class IIb



Approval area

Medical Devices


- 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.




Leone SPA

50-50019 Sesto

, Fiorentino (FI),



1. Screw endosteal dental implant, two-piece

Product Type

Single Device Product

Effective date



55849 Screw endosteal dental implant, two-piece

Intended purpose

Dental implants indicated for single or multiple tooth replacement, for use in terminal or intermediate

edentulous sites in the mandible and/or the maxilla, and for totally edentulous arches. The implants are

designed to be surgically inserted in the bone structure of the mouth in order to replace missing teeth. It

can work as a support for partial/total prosthetic restorations, either provisional or definitive, or as an

anchorage system for removable prostheses.

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

Public Summary

Page 1 of

Produced at 09.11.2017 at 11:21:01 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.

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