Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Xand Innovations Pty Ltd - Light, dental, polymerization activator
ARTG entry for
Medical Device Included Class 1
Xand Innovations Pty Ltd
F0705 / 34 Rothschild Avenue,Rosebury, NSW, 2018
ARTG Start Date
Medical Device Class 1
- 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.
35 Avenue du Gros Chene ZI des Bellevues
, Herblay, 95220
1. Light, dental, polymerization activator
Single Device Product
35775 Light, dental, polymerization activator
This device is an electrically powered lamp that is used to initiate the polymerization of resin based dental
materials as a temporary or permanent substance to replace missing tooth structure or materials used in
certain dental procedures.
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Produced at 02.11.2019 at 07:36:10 AEDT
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