Summary for ARTG Entry:
DIO Australia Pty Ltd - Screw endosteal dental implant, two-piece
ARTG entry for
Medical Device Included Class IIb
DIO Australia Pty Ltd
Level 11 / 33 York Street,SYDNEY, NSW, 2000
ARTG Start Date
Medical Device Class IIb
- 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.
66 Centum seo-ro Haeundae-gu Busan
Korea - Republic of
1. Screw endosteal dental implant, two-piece
Medical device system
55849 Screw endosteal dental implant, two-piece
DIO UF HSA Fixture components is indicated for surgical placement in the upper and lower jaw arches, to
provide a root form means for single or multiple units` prosthetic attachment to restore a patient`s chewing
function. The smaller(ø3.8 ~ ø5.5) fixtures can be placed with a conventional two stage surgical process
with an option for transmucosal healing or they can be placed in a single stage surgical process for
immediate loading when good primary stability is achieved with appropriate occlusal loading. The
larger(ø6.0 ~ ø7.0) fixtures can be placed with a conventional two stage surgical process with an option for
transmucosal healing and are indicated for the molar region with delayed loading.
No Specific Conditions included on Record
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