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

The Essential Solid implants are fitted with an internal octagonal conical connection combined with an external octagonal connection measuring 1.2 mm in height.

The Essential Cone implants are fitted with an internal octagonal conical connection.

The Essential ECK implants are fitted with a larger internal octagonal conical connection than that of the Essential Cone implants.

Immediate loading is appropriate for the Essential Cone and Essential Cone and Essential ECK implants when good primary stability is achieved with appropriate occlusal loading. Abutments can be used in single tooth replacements and multiple tooth restorations.

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

The Klockner Essential implant system consists of a group of implants, implant accessories and additional material to restore the mastication system. The different EC, ES and ECK models are available in three different diameters: 3.5mm, 4.0mm and the range of lengths varies between 8mm and 16mm. They are internally connected.

This document (K080224) is a 510(k) premarket notification for the Klockner Essential Dental Implants System. It aims to demonstrate substantial equivalence to previously cleared devices. Based on the provided text, the submission focuses on asserting equivalence based on intended use, composition, endosseous surface treatment, and design principles, rather than presenting a study with acceptance criteria and performance data in the way a diagnostic AI device would.

Therefore, a table of acceptance criteria and device performance, as well as details about sample sizes, expert adjudication, MRMC studies, standalone performance, training data, and ground truth for a study proving the device meets acceptance criteria, cannot be extracted from this document. These types of studies are typically not required or presented for dental implant submissions that demonstrate substantial equivalence through comparison to predicate devices, especially concerning their physical and material properties.

The relevant sections of the document are primarily focused on:

• Device Identification: Name, manufacturer, contact.
• Device Description: Physical characteristics (diameters, lengths, connection types) of the Klockner Essential implant system (EC, ES, ECK models).
• Intended Use: Surgical insertion into bone to replace tooth roots, acting as support for dental implants, with specific indications for different diameters and bone types, and considerations for immediate loading.
• Predicate Devices: Listing of previously cleared Klockner dental implants and other manufacturers' implants used for comparison.
• Basis for Substantial Equivalence: Stating that "the intended use, the composition and the endosseous surface treatment are identical to the Klockner predicate devices. The design principles are the same as the Klockner predicate devices."

In summary, this document does not contain the information requested in your prompt regarding acceptance criteria and a study demonstrating performance against those criteria because it's a 510(k) submission based on substantial equivalence to predicate devices, not a performance study of a novel diagnostic or AI-based device.

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Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.

Protective Caps are intended to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the healing phase for up to 6 months.

Temporary Copings are intended to serve as a base for temporary restorations for up to 28 days.

The Straumann P.004 Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surqical and prosthetic parts and instruments.

Abutments are placed into dental implants to provide support for prosthetic restorations, temporary copings support a temporary restoration out of occlusion and protective caps protect the abutment during the healing phase.

This document, K072071, is a 510(k) premarket notification for dental abutments, temporary copings, and protective caps. It claims substantial equivalence to previously marketed devices. Crucially, this submission does not describe a study involving device performance against acceptance criteria in the context of an AI/software device or a comparative effectiveness study involving human readers.

The document details the regulatory classification, intended use, and substantial equivalence to predicate devices (physical dental components). It confirms that the new devices have the same material composition, basic design, and fundamental operating principles as the cleared predicate devices.

Therefore, I cannot extract the requested information such as acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, or results of MRMC or standalone studies because this is not a study about an AI/software device.

Ask a specific question about this device