Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Numedical Pty Ltd - Scaler system handpiece, periodontic, ultrasonic
ARTG entry for
Medical Device Included Class IIa
Numedical Pty Ltd
9-13 Hender Avenue,Magil, SA, 5072
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.
Guilin Woodpecker Medical Instrument Co Ltd
Information Industrial Park Guilin National
High-Tech Information Park
Guilin, Guangxi, 541004
1. Scaler system handpiece, periodontic, ultrasonic
Single Device Product
44907 Scaler system handpiece, periodontic, ultrasonic
Ultrasonic dental scaling/debridement system handpiece; A hand-held component of an ultrasonic dental
debridement system intended to convert high frequency electrical current from a generator into an
ultrasonic oscillation, for a tip placed at its end to mechanically fragment and dislodge gross
debris/accretions during an endodontic and/or periodontal procedure. It may also serve as a conduit for
fluid intended to prevent overheating of the tip and surrounding tissue. This device is typically in the form
of a pen/pencil with attached cables. This is a reusable device.
No Specific Conditions included on Record
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Produced at 03.11.2017 at 05:58:37 AEDT
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