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The Brånemark Integration AB, implants and accessories is intended for surgical placement into the bone of upper /lower jaw arches as a permanent anchorage for prosthetic devices and to restore chewing function. The Brånemark Integration implants and accessories are subjected for one or two-stage surgical procedures, and either for cemented or screw retained prosthetic restorations. The implants are intended for immediate placement on a single tooth and/or multiple tooth applications recognizing sufficient bone stability (type I or II bone) and appropriate occlusal loading, to restore chewing and speech function. Multiple tooth applications may be connected with a bar.

The Brånemark Integration implant products that are subject of this 510(k) are threaded, root-form implants fabricated from commercially pure titanium, and machined and are commercially available.

The Brånemark Integration AB, FIXTURE ORIGINAL is intended for surgical placement into the bone of upper /lower jaw arches as a permanent anchorage for prosthetic devices and to restore chewing function.

The FIXTURE ORIGINAL consists of 4 implants, diameter 3,75 mm, and length from 8,5 to 15 mm.