Reguarde

Main information

  • Trade name:
  • Reguarde Resorbable Collagen Membrane - Collagen dental regeneration membrane
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Reguarde Resorbable Collagen Membrane - Collagen dental regeneration membrane
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216324
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216324

Implant Direct Oceania Pty Ltd - Reguarde Resorbable Collagen Membrane - Collagen dental regeneration

membrane

ARTG entry for

Medical Device Included Class III

Sponsor

Implant Direct Oceania Pty Ltd

Postal Address

33A Regent Street,KOGARAH, NSW, 2217

Australia

ARTG Start Date

22/10/2013

Product category

Medical Device Class III

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

Collagen Matrix Inc

15 Thornton Road

Oakland, NJ, 07436

United States Of America

Products

1. Reguarde Resorbable Collagen Membrane - Collagen dental regeneration membrane

Product Type

Single Device Product

Effective date

22/10/2013

GMDN

58709 Collagen dental regeneration membrane

Functional description

REGUARDE™ Collagen Membranes is a resorbable, cell-occlusive barrier membranes used in guided

tissue and bone regeneration procedures in oral surgery to manage oral wounds and assist in wound

healing.

Intended purpose

"REGUARDE™ Collagen Membrane is a bioresorbable, implantable collagen material (cell-occlusive

barrier membranes ) that is intended for use in periodontal and/or dental surgery procedures as a material

for placement in the area of periodontal and/or dental surgery procedures as a material for placement in

the area of periodontal defects, dental implant, bone defect or ridge construction to aid in wound healing

post surgery".

Variant information

Size (mm) 30mm X 40mm

Size (mm) 20mm X 30mm

Size (mm) 15mm X 20mm

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 05:20:33 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