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Straumann® dental implants for use in the pterygoid region are indicated in cases of severe jaw resorption for the functional and esthetic oral rehabilitation of the upper jaw in edentulous or partially edentulous patients. This indication is limited to Straumann® BLC bone-level implants with a length of 18 mm and a diameter of 3.75 mm (RB platform). Implants anchored in the pterygoid region shall be placed using a free-hand surgical technique and restored only in splinted applications utilizing at least two implants in combination with screw retained abutments.

The subject devices are part of the Straumann® Dental Implant System, which is an integrated system of endosseous dental implants with corresponding abutments and healing components as well as instruments and prosthetic parts. Straumann® dental implants are solid screw implants with a bone anchorage surface that is large-grit sandblasted and acid-etched. Straumann® dental implants can be used following the extraction or loss of natural teeth to restore chewing function. Within the scope of this submission, the Straumann® BLC bone-level implants (diameter 3.75 mm, length 18 mm) are intended for surgical placement in the pterygoid region of the maxilla to provide posterior support for multi-unit, splinted prosthetic restorations. The implants are to be used only in combination with compatible screw-retained angled abutments (17° or 30°) and are not intended for single-unit or single-tooth restorations.

This premarket notification seeks to expand the previously cleared indications for use of the Straumann® BLC implants (K230108) to include anchorage in the pterygoid region, without changes to the fundamental device design, materials, surface characteristics, or implant-abutment connection.

The subject BLC implants indicated for the pterygoid application are provided in a single prosthetic platform identified as RB (Regular Base) for Ø 3.75 mm diameter implant (18 mm length only).

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