Summary for ARTG Entry:
Ultradent Australia Pty Ltd - Absorbent, <specify>
ARTG entry for
Medical Device Included Class 1
Ultradent Australia Pty Ltd
PO Box 111,Coogee, NSW, 2034
ARTG Start Date
Medical Device Class 1
- 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.
Ultradent Products Inc
505 W 10200 S
South Jordan, Utah, 84095
United States Of America
1. Absorbent, <specify>
Single Device Product
40532 Absorbent, <specify>
For optimum fissure drying and preparation. PrimaDry contains 99% organic solvents and 1% primer.
Thus, PrimaDry rapidly volatilizes moisture content of fissures after rinsing off etchant with waterspray and
airdrying. The ultrafine primer film allows UltraSeal XT plus to flow perfectly into every fissure. Also useful
prior to placing composite repairs. Do not use on dentin.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 03:35:58 AEDT
This is not an ARTG Certificate document.
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