Australia - English - Department of Health (Therapeutic Goods Administration)

osstem australia pty ltd - 38347 - drill, dental, electrically powered handpiece - a dental device that consists of a single handpiece which includes a chunk for attaching dental burs, reamers and similar rotating devices used in dentistry. the device incorporates an electric motor.

Australia - English - Department of Health (Therapeutic Goods Administration)

osstem australia pty ltd - 58709 - collagen dental regeneration membrane - cytoplast? collagen membranes is a resorbable, cell-occlusive barrier membranes used in guided tissue and bone regeneration procedures in oral surgery to manage oral wounds and assist in wound healing. a sterile bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, and to regenerate bone defects around implants and at sites intended for implant placement, by acting as a barrier to prevent the down-growth of soft tissue into the underlying bone during the healing period. it is a pliable material made of animal derived collagen (e.g., porcine) which may be fixed to soft tissues with sutures; it is applied between soft tissue and bone during periodontal flap surgery applied to grafted bone defects in guided bone regeneration (gbr) and guid tissue regeneration (gtr) procedures. this is a single-use device.

Australia - English - Department of Health (Therapeutic Goods Administration)

osstem australia pty ltd - 17467 - suture, polytetrafluoroethylene - the cytoplast ptfe suture is a non-absorbable, sterile surgical monofilament suture composed of polytetrafluoroethylene that has been expanded to produce a microporous structure (e-ptfe). the cytoplast ptfe suture meets all usp and ep requirements (diameter, knot-pull, and needle-pull). the suture is undyed and contains no additives. the cytoplast ptfe suture is supplied sterile with attached standard surgical needles in a variety of sizes.

Australia - English - Department of Health (Therapeutic Goods Administration)

osstem australia pty ltd - 44908 - scaler system tip, periodontic, ultrasonic - a device (also known as an insert), which is part of an ultrasonic scaler system, that is attached to a dedicated handpiece which together deliver ultrasonic energy (e.g., 25khz/30khz) transmitted from the generator to the oral cavity for the removal of accretions from tooth surfaces during oral prophylaxis and periodontal therapy. this device vibrates at a high frequency to provide the scaling effect. water or a rinsing solution (e.g., chlorhexidine) is also fed through the handpiece/tip assembly to assist in the process. this device comes in a variety of designs and tip shapes and is reusable.

Australia - English - Department of Health (Therapeutic Goods Administration)

osstem australia pty ltd - 36047 - scaler system, periodontic, ultrasonic - a collection of devices using ultrasonic energy in a vibrating tip for the removal of accretions from tooth surfaces during oral prophylaxis and periodontal therapy. it typically consists of the energy-generating unit, which may contain the water or rinsing solution (e.g., chlorhexidine) source, a handpiece with connecting cable, the insert tip (the distal end of the system used in the oral cavity) and a foot control. this device is used for oral hygiene and periodontal debridement, e.g., removal of plaque, biofilm, and gross calculus from shallow to deep periodontal pockets. it can also be used for the removal of orthodontic cement.

Australia - English - Department of Health (Therapeutic Goods Administration)

osstem australia pty ltd - 38763 - remotely-driven dental drilling system motor - this is a dental device that incorporates an electric motor used with a flexible drive system providing power for a dental handpiece.

Australia - English - Department of Health (Therapeutic Goods Administration)

osstem australia pty ltd - 58503 - pliable-polymer dental regeneration membrane, tacked - cytoplast txt-200, ti-series are manufactured from high-density ptfe, which is engineered to withstand exposure. this key feature, coupled with the cytoplast technique for grafting extraction sites, offers the ultimate in both predictability and esthetics during dental bone grafting procedures.

Australia - English - Department of Health (Therapeutic Goods Administration)

osstem australia pty ltd - 44772 - tubing set, irrigation pump - a collection of flexible tubing, typically sterile, and associated items that may include clamps, filters, and connectors, used with an irrigation pump to deliver irrigation solution to a device (e.g., an ablation catheter) at a specified flow rate during a procedure (e.g., cardiac electrophysiology ablation). the tubing is made of synthetic material and is of a fixed diameter that is specific to the requirements of the pump. the contents of the set are single-use.

Australia - English - Department of Health (Therapeutic Goods Administration)

osstem australia pty ltd - 31823 - dental drilling system attachment - a device, e.g., a straight, contra-angle or right-angle attachment, that is connected to a drill handpiece to achieve a specific function such as accessing intraoral areas that are difficult to reach when cleaning teeth, or preparing dental cavities for restorations (e.g., fillings) or preparing teeth for crowns and bridges. this is a reusable device.

Australia - English - Department of Health (Therapeutic Goods Administration)

osstem australia pty ltd - 40958 - pneumatic dental drilling system handpiece - a hand-held dental device that includes a chuck for attaching dental drills, burs, reamers, and similar rotating devices used in dentistry to bore/excavate bones, teeth, and tough tissues. the device incorporates a small turbine motor normally driven by compressed air and which typically has a built-in water spray for cooling the rotating device. the handpiece is typically connected through the dental delivery system or a freestanding independent system. this is a reusable device.