Summary for ARTG Entry:
Dentrac Pty Ltd - Orthodontic appliance, attachment
ARTG entry for
Medical Device Included Class IIa
Dentrac Pty Ltd
46 High Street,CARLTON, NSW, 2218
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.
Zhejiang Protect Medical Equipment Co Ltd
Science & Technology Zone Xiaofeng Town
Anji City, Zhejiang,
1. Orthodontic appliance, attachment
Single Device Product
41059 Orthodontic appliance, attachment
This is a ceramic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic
wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the
position of the tooth. This is a single-patient device that is used for the duration of the treatment
(single-use) before being discarded.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 03:24:03 AEDT
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