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

emergo asia pacific pty ltd t/a emergo australia - 50484 - dental cad/cam system application software - the software is intended to be used for simulation of surgical interventions and the planning of preoperational interventions. the software is used to assist in the positioning of orthopedic components.

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

johnson & johnson medical pty ltd t/a depuy synthes - 43025 - dental occlusal splint, custom-made - a rigid or flexible custom-made device intended to overlay the occlusal surfaces of the teeth to maintain the position of displaced or moveable teeth, to treat teeth clenching and bruxism and their sequelae, or to provide temporary relief from muscle or temporomandibular joint pain.

Singapore - English - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - orthopaedics - proplan cmf guides are intended to be used as surgical tools to transfer a preoperative plan to surgery. proplan cmf guides are intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures.

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

emergo asia pacific pty ltd t/a emergo australia - 50483 - orthopaedic cad/cam system application software - device is intended for use as software for computer assisted design and manufacturing of medical exo- and endo-prostheses, patient specific medical and dental/orthodontic accessories and dental restorations.

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

dentsply sirona pty ltd -

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

dentsply ih pty ltd -

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

dentsply ih pty ltd -

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

aa-med pty ltd - 13180 - orthopaedic prosthesis implantation instrument, reusable - materialise standard+ solutions instruments are intended to facilitate the implantation of materialise standard+ solutions plates and screws and are reusable devices intended to be sterilized prior to use. materialise standard+ solutions instruments are hand-held surgical instrument intended to be used during implantation of craniomaxillofacial implants. these may be used either for preparing the screw fixation of the implants or for bending the plates to fit the patient?s anatomy or as an interface between implants and/or implantation components.

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

emergo asia pacific pty ltd t/a emergo australia - 44270 - cad/cam unit software - intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a ct scanner or a magnetic resonance imaging scanner to an output file. it is also intended as pre-operative software for simulating / evaluating surgical treatment options. the device is not intended to be used for mammography imaging.

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

zimmer biomet pty ltd - 40872 - mri system, application program software - software used pre-operatively as a planning tool to determine reference alignment axes in relation to anatomical landmarks based on mri images of the patient.