Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Kerr Australia Pty Ltd - Dental digital imaging sensor, intraoral
ARTG entry for
Medical Device Included Class IIa
Kerr Australia Pty Ltd
Unit 10 112-118 Talavera Road,NORTH RYDE, NSW, 2113
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.
Dental Imaging Technology Corporation
1910 North Penn Road
Hatfield, PA, 19440
United States Of America
1. Dental digital imaging sensor, intraoral
Single Device Product
44905 Dental digital imaging sensor, intraoral
this is an analogue device that is temporarily placed in a patient's mouth that is inteded to be used to
perform routine diagnostic dental imaging procedures.
No Specific Conditions included on Record
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Produced at 03.11.2017 at 05:17:53 AEDT
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