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The Klockner Essential implant system is especially designed for surgical insertion into the bone to replace the root of the teeth, acting as the support for the dental implants formed by implant accessories.

The Essential Cone 1.5 implants are fitted with an internal octagonal conical connection. Immediate loading is appropriate for the Essential Cone 1.5 implants when good primary stability is achieved with appropriate occlusal loading.

8mm Implants are not indicated for use as single implants and for immediate load.

The Klockner Essential Cone 1.5 implant system consists of a implants to restore the mastication system. The different EC 1.5 are available in four different diameters: 3.5mm, 4.0mm, 4.5mm and 4.8mm and the range of lengths varies between 8mm and 16mm. They are internally connected.

I am sorry but the provided text describes a 510(k) premarket notification for a dental implant system (Klockner Essential Implant System Models Essential Cone 1.5). This type of document focuses on establishing substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance data often found in clinical trials or AI/software validation studies.

Therefore, I cannot extract the information required concerning acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document primarily states that the device is "substantially equivalent to the previously cleared Klockner Essential Cone (EC) dental implants system cleared in K080224 because the intended use, the composition and the endosseous surface treatment are identical to the Klockner Essential predicate devices. The design principles are the same as the Klockner Essential predicate devices." This means the product is considered safe and effective based on its similarity to an already approved device, not on a new, explicit performance study against defined acceptance criteria.

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