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

dentsply sirona pty ltd - 55844 - basket endosteal dental implant, two-piece - mis dental implants are titanium root-shaped, screw-type implants designed for both two-stage and single stage procedures, with an internal thread for screwed abutment. they are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. the implants are sand blasted and acid etched and have a rough surface that enables osseointegration with the bone. there are various kinds of implants with different technological characteristics and with different lengths, diameters and platforms. different dental implant systems with different type of implant-abutment connection are designed, developed, manufactured and marketed by mis. the implants are a two-piece device to be used in combination with a wide range of abutments provided in order to aid in the prosthetic rehabilitation (cover screws, healing caps, cement-retained abutments, screw retained abutments etc.). this is a single-use device.

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

dentsply sirona pty ltd - 44880 - dental implant suprastructure device, temporary - this group contains abutments intended for temporary use (up to 6 months). this group contains healing caps and cover screws, titanium or peek temporary abutments. the temporary abutments are used in order to maintain an acceptable function and esthetic appearance until a permanent restoration is placed, as well as to shape the emergence profile of the soft tissue for future appropriate fitting of a permanent abutment. these are single use devices.

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

southern implants australia pty ltd - 44879 - dental implant suprastructure device, permanent - the tib abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. the tib abutments consist of two major parts. specifically, the titanium base and mesostructure components make up a two-piece abutment. the system integrates multiple components of the digital dentistry workflow: scan files from desktop scanners, cad software, cam software, ceramic material, milling machine and associated tooling and accessories. the intended use for the tib narrow abutments used with the ?3.0 mm external hex and ?3.0 mm deep conical implants is limited to replacement of maxillary lateral incisors and mandibular lateral and central incisors.

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

implant solutions pty ltd (trading as osteon medical) - 44880 - dental implant suprastructure device, temporary - healing abutments are used as an auxiliary transmucosal abutment. healing abutments are placed to cover the implant connection during the period between implant placement and final abutment placement. these healing abutments promote healing of the surrounding soft tissue after implant placement and inhibit epithelial downgrowth, establish a connective bone tissue attachment and retain the bone.

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.

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

nobel biocare australia pty ltd - 44880 - dental implant suprastructure device, temporary - these are prefabricated device that are intended to be used on a temporary basis to create the necessary suprastructure to be used during dental implant restorative and laboratory procedures to provide a base for a temporary restoration during the healing and sculpturing period of the soft tissue prior to the fabrication and installation of the final restoration. such as healing abutments, cover screws and temporary abutments and clinical screws.

Singapore - English - HSA (Health Sciences Authority)

straumann group & clear correct singapore pte. ltd. - dental - straumann screw-retained abutments are intended to be placed into straumann dental implants to provide support for prosthetic reconstructions such as crowns and bridges. coping are fixed to abutments in order to provide support for prosthetic reconstructions such as crowns, bridges and bar-retained over-dentures.

Singapore - English - HSA (Health Sciences Authority)

straumann group & clear correct singapore pte. ltd. - dental - prosthetic components directly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilations. straumann abutments are intended to be placed into straumann dental implants to provide support for prosthetic reconstructions such as crowns and bridges. copings are fixed to abutments in order to provide support for prosthetic reconstructions such as crowns, bridges and bar-retained over-dentures. healing caps, closure caps and healing abutments are intended for use with the straumann dental implant system (sdis) to protect the inner configuration of the implant and maintain, stabilise, and form the soft tissue during the healing process.

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

biomet 3i australia pty ltd - 44879 - dental implant suprastructure device, permanent - bellatek express and flex abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. a dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. the prosthesis can be screw retained or cement retained. all digitally designed superstructures and/or hybrid abutment crowns for use with bellatek express or bellatek flex abutments are intended to be sent to a biomet 3i validated milling center for manufacture.

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

dentsply sirona pty ltd - 44879 - dental implant suprastructure device, permanent - this group contains abutments intended for permanent use. the superstructures are dental components for holding the prosthetic restoration, which are connected to a multi-component system (such as an overdenture abutment, connect abutment or multi-unit abutment), and are connected above the gingival tissue. in addition, this group includes prosthetic screws used to connect screw-retained abutments to the implants or bridge suprastructure. the prosthetic screw does not penetrate a tooth or enter the gum or bone beyond the tooth. these are single use devices.