Straumann® RidgeFit Implants

The Straumann® RidgeFit Implants are tapered dental implants with a 2.4 mm diameter, made from Roxolid® (titanium-zirconium alloy) with an SLA surface finish and titanium nitride–coated Optiloc® attachment element. They are indicated for endosteal implantation in fully edentulous patients to stabilize removable dentures, requiring a minimum of 4 implants in the mandible and 6 in the maxilla, with options for immediate or conventional loading depending on primary stability.

The subject device has 2 cutting flutes (versus 3 in the predicate) with an average depth of 0.43 mm (18% shallower than the predicate's 0.52 mm), and constant thread depth of 0.33 mm (versus varying non-uniform depth in the predicate). It is identical in diameter (2.4 mm), available lengths (10, 12, 14 mm), material (Roxolid®), neck heights (2.8, 3.8, 4.8 mm), TiN coating, SLA surface treatment, and anchor ball abutment connection to the primary predicate K211052.

ISO 14801 (dynamic loading test for endosseous dental implants), ISO 10993-1:2018 (biocompatibility evaluation), ISO 11137-1:2006 (sterilization validation using VDmax25 method), ISO 11607-1:2019 (packaging stability), ASTM F1886, ASTM F1929, and ASTM F88 (shelf-life and packaging studies). Performance testing included insertion torque, torque-to-failure, and MRI conditional simulation testing.

Although the subject device has 2 cutting flutes instead of 3 and slightly shallower cutting flute depth (18% reduction) compared to the predicate, the submission demonstrates substantial equivalence through performance testing showing equivalent global geometry, dimensions, dynamic fatigue resistance, insertion torque, and torque-to-failure performance. The reduced flute depth and number do not compromise function because the overall implant geometry and load-bearing characteristics remain the same, and the predicate itself differs from reference devices in similar geometric parameters while maintaining equivalence.