Summary for ARTG Entry:
Implant Direct Oceania Pty Ltd - Reguarde Resorbable Collagen Membrane - Collagen dental regeneration
ARTG entry for
Medical Device Included Class III
Implant Direct Oceania Pty Ltd
33A Regent Street,KOGARAH, NSW, 2217
ARTG Start Date
Medical Device Class III
- 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.
Collagen Matrix Inc
15 Thornton Road
Oakland, NJ, 07436
United States Of America
1. Reguarde Resorbable Collagen Membrane - Collagen dental regeneration membrane
Single Device Product
58709 Collagen dental regeneration membrane
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
"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
Size (mm) 30mm X 40mm
Size (mm) 20mm X 30mm
Size (mm) 15mm X 20mm
No Specific Conditions included on Record
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Produced at 10.11.2017 at 05:20:33 AEDT
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