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The Sargon Non-Expandable Dental Implant is indicated for immediate placement or delayed placement in the bone of the upper or lower jaw to support prosthetic devices such as artificial teeth, crowns, bridges or overdentures in partially or fully edentulous patients and to restore the patient's chewing function. This device is not indicated for immediate loading.

The Sargon Non-Expandable implant is a root form endosseous dental implant (FDA classification code DZE). It has been placed in class 2 per (1 DA Classification code DEE). is fabricated from titanium alloy meeting the specifications of ASTM F136. It is available in lengths of 8, 10, 13, and 16mm and diameters of 4.3 and 5.1mm. The surface is grit blasted and acid etched. The device is provided sterile. Sterility is achieved by gamma radiation pursuant the devilos provide a sterility assurance level (SAL) of 10°.

For immediate load use, without an abutment, in either partially or fully edentulous mandibles and maxillae, for fixed or detachable prosthesis and for use in support of free-standing restorations with or without the involvement of adjacent dentition.

The product is an endosseous dental implant for prosthetic attachment; trade name: Sargon Immediate Load Implant™. It is substantially equivalent to previously marketed models of this device described in premarket notifications K930071 and K961005. In this design, the collar is longer and allows the direct fixation of a prosthesis to the implant with or without the use of an abutment. The material is the same as the predicate devices; i.e., titanium alloy conforming to ASTM standard F136 "Standard Specification for Wrought Titanium 6Al-4V Ell Alloy for surgical Implant Applications."