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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°.

The provided text is a 510(k) summary for a dental implant device (K082573). It details the device's description, intended use, and claims of substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

510(k) submissions typically demonstrate substantial equivalence to a legally marketed predicate device rather than presenting new performance studies against specific acceptance criteria. This means the device is deemed safe and effective because it is very similar to another device that has already been cleared by the FDA.

Therefore, I cannot provide the requested table or answer the questions related to studies, sample sizes, ground truth, or expert involvement, as this information is not present in the provided document.

To clarify, here's what is available in the document regarding how equivalence was established:

• Basis for Substantial Equivalence: The Sargon Non-Expandable Dental Implant is claimed to be substantially equivalent to certain Strauman implants (K012757, K003271, K033984) and previously cleared Sargon expandable implants (K930071, K961005, K981141).
• Equivalence Factors: This equivalence is based on "material composition, implant dimensions (e.g., Strauman K033984; lengths 8, 10, 13, 16; diameters 3.3, 4.1, 4.6), surface treatment and individual or abutment design." It also states "There are no new indications or materials as compared with the predicate devices."

This is the extent of the performance "proof" provided in this type of submission.

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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."

The provided text describes a 510(k) summary for the Sargon Immediate Load Implant, but it does not contain information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The document is a regulatory submission for a dental implant, focusing on its substantial equivalence to previously marketed devices. It details the device's material, indications for use, and confirms FDA clearance. Regulatory letters and forms are included, but there is no technical study data or performance metrics.

Therefore, I cannot provide the requested information based on the given input.

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