Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Henry Schein Halas - X-ray film, diagnostic imaging, dental, non-screen
ARTG entry for
Medical Device Included Class IIa
Henry Schein Halas
Locked Bag 5003,ALEXANDRIA, NSW, 2015
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.
Carestream Health Inc
150 Verona Street
Rochester, New York, 14608
United States Of America
1. X-ray film, diagnostic imaging, dental, non-screen
Single Device Product
40978 X-ray film, diagnostic imaging, dental, non-screen
These intraoral dental films are basically recording films that is used in dentistry. A non-screen x-ray film
specifically sized and designed for use with dental x-ray systems. It is designed for direct exposure to
x-rays and is relatively insensitive to the visible light emitted from screen
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Produced at 02.11.2019 at 03:20:32 AEDT
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