Dental

Main information

  • Trade name:
  • Dental implant suprastructure kit
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Dental implant suprastructure kit
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216971
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216971

Straumann Pty Ltd - Dental implant suprastructure kit

ARTG entry for

Medical Device Included Class IIb

Sponsor

Straumann Pty Ltd

Postal Address

Unit 12/7 Gateway Circuit,PORT MELBOURNE, VIC, 3207

Australia

ARTG Start Date

6/11/2013

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

Institut Straumann AG

Peter Merian Weg 12

Basel, , CH 4002

Switzerland

Products

1. Dental implant suprastructure kit

Product Type

Procedure Pack

Effective date

6/11/2013

GMDN

44881 Dental implant suprastructure kit

Intended purpose

A collection of prefabricated dental devices and components used to create a suprastructure on a dental

implant to mimic preparations of natural teeth. It is used during dental implant restorative and laboratory

procedures and will typically consist of a direct dental abutment (the device that is screwed into the

surgically implanted fixture that creates the anchorage for the prosthetic tooth in the mandible or maxilla),

a carrier, an impression pick-up, a replica, a healing cap and a burnout cylinder. This is a single-use

device.

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 03:44:58 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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