Straumann® BLC Implants - Indication Widening

Straumann® BLC Implants are endosseous dental implants (titanium-13 zirconium alloy with sandblasted and acid-etched surface) intended for surgical placement in the pterygoid region of the maxilla to support multi-unit, splinted prosthetic restorations in patients with severe jaw resorption. The specific devices addressed are bone-level implants with 3.75 mm diameter and 18 mm length, used only with screw-retained angled abutments (17° or 30°) and at least two implants in splinted applications.

The subject devices have identical material (Titanium-13 Zirconium/Roxolid®), surface treatment (hydrophilic SLActive® and SLA®), sterilization method (gamma irradiation), implant-abutment connection (TorcFit with conical fitting), and thread pitch (0.8 mm) compared to the reference device K230108. The design is an apically tapered bone-level implant with threaded geometry for mechanical fixation, comparable to the primary predicate K212785 which also uses threaded root-form implants.

ISO 10993-1 (biocompatibility evaluation), ISO 11137-1:2006 and ISO 11137-2:2013 (sterilization validation), ISO 14801 (dynamic loading test for dental implants), and FDA Guidance documents on sterility, MR safety testing, and special controls for endosseous dental implants.

The subject devices are substantially equivalent because they have identical design, materials, surface characteristics, and implant-abutment connection to the reference device K230108, with no changes to fundamental device design. The indication for use (pterygoid region placement with splinted restorations requiring multiple implants in severe jaw resorption) is substantially equivalent to the predicate K212785, which also describes pterygoid placement for the same patient population. Clinical literature demonstrates that implants with comparable dimensions and configurations achieve high survival rates (96.5–100%) in pterygoid applications, and insertion torque testing confirms primary stability performance under the proposed conditions of use without raising new safety or effectiveness questions.