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

symbios orthopaedics pty ltd - 62249 - custom-made anatomy model/surgical guide kit - a set of single use instruments intended to be used in an orthopaedic procedure. it includes patient specific cutting guides to assist in the intraoperative orientation of implant components and other relevant disposable instruments relevant to the positioning of the cutting guides and also may contain relevant bone models. the devices are supplied sterile in a single box.

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

the australian centre for complex integrated surgical solutions - 62215 - custom-made anatomy model - the patient matched anatomical model is a model (physical and/or virtual) of an organ (e.g., heart, kidney, lung), bone or other anatomical feature of a specific patient intended to be used to assist anatomical visualization and surgical treatment planning. the physical model is created using additive (three-dimensional [3-d] printing) processes based on patient medical images which have been segmented and transformed into virtual anatomical models. the physical model is typically made of a synthetic polymer, marked with a unique identifier, and may be sterilized prior to use in sterile fields when produced and provided as sterilisable.

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

queensland health - metro north hospital and health service - 62215 - custom-made anatomy model - the patient matched anatomical model is intended to be used in the planning of clinical procedures to assist anatomic visualization, case education, and/or surgical treatment planning. the device is intended to be used by a trained medical professional who is familiar with the specific patient case. the device is intended for the particular case as identified by the requesting medical professional.

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

stryker australia pty ltd - 62215 - custom-made anatomy model - anatomical bone model intended to be used by the surgeon as an anatomical reference in planning and performing the implantation of patient-fitted temporomandibular reconstruction prostheses

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

aa-med pty ltd - 62249 - custom-made anatomy model/surgical guide kit - cmf plastic guides and cmf orthognatic splints are intended to be used as surgical tools to transfer a preoperative plan to surgery. cmf plastic guides are intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. cmf orthognatic splints are intended to align the maxilla and/or mandible in orthognathic surgical procedures. the subject devices are intended for single use only.

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

biomet 3i australia pty ltd - 61640 - dental implant abutment analog - implant analogs are used for simulation of dental implant connection and position on a stone or resin master model.

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

biomet 3i australia pty ltd - 61642 - dental implant analog - a metal post used in restorative dentistry to locate the implant in the dental impression.

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

dr k y lee pty ltd - 61640 - dental implant abutment analog - dental instrument used to confirm the orientation/position of the final dental abutment

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

henry schein halas - 61640 - dental implant abutment analog - a rod-like device intended to be used as a copy of a dental abutment, for a dental laboratory working model, to confirm the orientation/position of the final dental device; it may be used during a scanning procedure (e.g., with a laboratory scanner). this is a reusable device.

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

biomet 3i australia pty ltd - 61646 - dental implant prosthetic screw analog - waxing screws are intended for laboratory use during the wax-up procedures of implant abutments (or restorations) to prevent the screw-access hole from becoming ?blocked?; they are removed for the burn-out stage after the investment has been poured so that it can flow into the hole provided by the waxing screw. try-in screws are intended to be used during stages of laboratory fabrication of implant abutments or restorations to verify fit, seating, and/or placement of a screw-retained abutment or prosthesis on a cast (stone) model.