Summary for ARTG Entry:
Pacific Dental Specialties Pty Ltd - Bone matrix implant, artificial
ARTG entry for
Medical Device Included Class IIa
Pacific Dental Specialties Pty Ltd
PO Box 192,SANCTUARY COVE, QLD, 4212
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.
Osteogenics Biomedical Inc
4620 71st Street Building 78-79
Lubbock, TX, 79424
United States Of America
1. Bone matrix implant, artificial
Single Device Product
17751 Bone matrix implant, synthetic
This is cytoplast non resorbalbe membrane that is constructed of non-expanded polytetrafluorethylene
(PTFE) that may be reinforce by titanium. It is intended to be used as a matrix of synthetic material as a
scaffold in dental procedures to temporarily fill a cavity during bone augmentation.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 04:32:33 AEDT
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