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

andarsyn pty ltd - 34782 - dental bonding agent, polymer based - a material, primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material. it includes a resin-based bonding agent and may also include a primer and/or etching solution. it may also be used as an enamel bonding material.

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

ainsworth dental company pty ltd - 34811 - dental material, modelling, polymer based - this is a photosensitive polymer resin based liquid material that is intended to be used as a 3d printing liquid for the manufacture and fabrication of dental devices such as surgical guides, orthodontic models, retainers, aligners and any other device required to be used a device that is to be placed in the mouth

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

numedical pty ltd - 34782 - dental bonding agent, polymer based - dentine bonding agent/set: a material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material. it includes a resin-based bonding agent and may also include a primer and/or etching solution (as a single formulation or as part of a set); composite resin is not included. it may also be used as an enamel bonding material. after application, this device cannot be reused.

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

vicki partridge pty ltd - 60702 - clinical information system web-based application software - clinicalvision 5.3 is a web based electronic medical record (emr) which supports in-center, home and acute end stage renal disease patient care. the software provides reporting tools for extracting patient, team, organization and cost information and interfaces with dialysis systems and other clinical information systems to automatically integrate all clinical information into a single complete patient record.

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

ivoclar vivadent pty ltd - 45081 - dental material, root-filling, polymer-based - a device made from a polymer-based synthetic gutta-percha intended to fill the root canal of a tooth.

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

philips electronics australia ltd - 58884 - self-care monitoring web-based application software - a web based clinical and patient decision support software platform intended to aid in remote communication and care management between patients, their informal caregiver, and healthcare providers. collects, stores, displays, sorts, analyzes, and transfers health related patient information enabling healthcare providers to remotely educate, motivate, and communicate with their patients. intended to support patient populations as determined by the healthcare provider and can be configured to develop specific care plans for patients or populations with health related risk factors (for example hypertension and diabetes). an informational tool and does not generate recommendations for clinical diagnosis or treatment decisions. all patient medical diagnosis and treatment are to be performed under the direct supervision and oversight of an appropriate healthcare provider.

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

headup labs pty ltd - 58884 - self-care monitoring web-based application software - an app-based software program intended to be used by a patient in a non-clinical environment to provide general health assessment information and/or health advice through an interactive platform. the software is intended to collect patient information (demographics, lifestyle data) and feedback information to indicate the general health/wellness in key areas (e.g., mental, cardiovascular) and/or assist the patient in deciding the best course of action if they are unwell (e.g., see a clinician, self-treatment for minor ailments).

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

seer medical holdings ltd - 58884 - self-care monitoring web-based application software - the 'seer app: epilepsy management' allows for the recording of events such as seizures, dizziness, and moods. these recorded events will be integrated along with other data such as medication timing, environmental, sleep, and other sensor data from the mobile device and/or connected wearables. the app can then display event trending, alerts, recommendations, and risk assessment to the person based on extrapolated historical patterns, such as seizure cycles.

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

healthware aus pty ltd - 34782 - dental bonding agent, polymer based - an unfilled resin used to assist the mechanical adhesion of a composite restorative material to etched enamel. bonding of direct/indirect restorations for all cavity classes using light-curing, dual-curing, or self-curing methacrylate-based composites/compomers. bonding of fissure sealants. enamel etching and enamel/dentine etching prior to the adhesive bonding.

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

silvercloud health australia pty ltd - 61087 - clinical management support web-based application software - the silvercloud health platform is intended to be used as an internet-based cognitive behavioural therapy (icbt) to help adults and children manage their mental health and well being. the silvercloud health platform is designed to alleviate the signs and symptoms of depression, anxiety, ocd, and other mental health conditions. the platform includes various programmes and modules intended to be used with a trained professional to support and monitor the user's progress.