Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Numedical Pty Ltd - Denture base resin, thermoplastic
ARTG entry for
Medical Device Included Class 1
Numedical Pty Ltd
9-13 Hender Avenue,Magil, SA, 5072
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.
BH Medical Products Co Ltd
No90 Shenjiang Villagers' Group
Zhangjiacunwei Xilin Street Zhonglou District
Changzhou City, Jiangsu Province,
1. Denture base resin, thermoplastic
Single Device Product
58288 Denture base resin, thermoplastic
Denture base resin, thermoplastic; A thermoplastic material intended to be used in the dental laboratory to
manufacture a temporary, partial, or fully-removable denture base (the portion of a denture that rests on
the oral mucosa and retains the artificial teeth); it may also be used to manufacture occlusal splints and
night guards. The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank] is
manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the
shape needed for the patient. After application, this device cannot be reused.
No Specific Conditions included on Record
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Produced at 03.11.2017 at 12:58:40 AEDT
This is not an ARTG Certificate document.
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