(684 days)
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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.