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The Stern IC Dental implant System is intended for long term surgical implantation in the bone of the patient's upper or lower arch to provide immediate load or delayed load of prosthetic systems, such as artificial teeth, in order to restore the patient's chewing function. The Stern IC Dental Implant System is also indicated for immediate loading with good primary stability and appropriate occlusal loading. The Stern IC Dental Implants are compatible with the Straumann Rn Synocta , Straumann SynOcta Meso Abutments, Straumann RC Temporary Abutments, and the Straumann RC Cementable abutments. The Stern IC Dental Implant System is only intended for use with straight abutments.

The Stern IC Dental device is a root-form dental implant with a screw-type body, acid etched except for the neck of the implant, which is machined to a smooth finish. It is manufactured from pure grade 4 titanium with a flared neck, used for one-stage, transgingival or subgingival implantation. The neck and body include an internal taper and octagon. The implants are composed of grade 4 commercially pure titanium and are available in a range of lengths and diameters. This submission also includes healing abutments, solid abutments, and cover screws which are used as accessories to the dental implants. The implant components are manufactured from pure, implant-grade titanium alloy and are equivalent in terms of materials, performance specifications, manufacturing, manufacturing equipment, packaging materials and design as other Sterngold abutments and cover screws previously approved via K892124 and K924219. The Stern IC Dental Implants and abutments are compatible with the Straumann Rn Synocta (K073628), Straumann SynOcta Meso Abutments (K033243), Straumann RC Temporary Abutments, (K093027) and the Straumann RC Cementable abutments (K072071). The Stern IC Dental Implant System is not intended for correction of implant fixtures placed at an angle. It is only intended for use with straight abutments. The proposed Stern IC Dental Implant will be available in a range of lengths and diameters.