Summary for ARTG Entry:
One Dental Pty Ltd - Prophylaxis cup
ARTG entry for
Medical Device Included Class IIa
One Dental Pty Ltd
Unit 8 /9 Packard Avenue,CASTLE HILL, NSW, 2154
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.
Peng Lim Enterprise Co Ltd
Number 42 Wanxing Street
Sanmin District., Kaohsiung, 807
Taiwan (Province of China)
1. Prophylaxis cup
Single Device Product
16184 Prophylaxis cup
A device, typically made from rubber, that is used to apply polishing agents during dental prophylaxis
(cleaning). The device is held in a dental handpiece, which spins the prophylaxis cup as the polishing
agent is applied to the teeth.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 09:57:47 AEDT
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