Summary for ARTG Entry:
Ivoclar Vivadent Pty Ltd - Denture reliner, elastic, long-term
ARTG entry for
Medical Device Included Class IIa
Ivoclar Vivadent Pty Ltd
PO Box 367,NOBLE PARK, VIC, 3174
ARTG Start Date
Medical Device Class IIa
- 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.
Detax GmbH Co KG
Ettingen, , 76275
1. Denture reliner, elastic, long-term
Single Device Product
34770 Denture reliner, elastic, long-term
This is a material that is intended to be used under a denture to be placed in the mouth for long term use
as a soft reline material.
This relining material consists of polymer based material and is applied as a coating / lining on the denture
base, thus facilitatng a new fitting surface to a denture - implying better fit and retention while relining an
intraoral removable long term prosthesis.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 06:39:42 AEDT
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