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The KLOCKNER® VEGA® dental implant system is indicated to replace missing teeth in single and multiple unit applications within the mandible or maxilla. Implants can be for immediate placement and function in extraction sites and partially or completely healed alveolar ridge situations, when good primary stability is achieved and with appropriate occlusal loading. Different loading protocols (immediate, early or delayed) can be applied in partially or totally edentulous patients. The prosthetic restorations can be single-unit or multiple-unit restorations.

The Ø 3.0 mm implants should only be used for unit restorations for maxillary lateral incisors and mandibular lateral and central incisors.

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This document is a 510(k) clearance letter for the Klockner Vega Dental Implant System and does not contain the requested information about acceptance criteria and a study proving device performance.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory requirements, such as registration, labeling, and good manufacturing practices, but does not include any performance data or details of a study.

Therefore, I cannot provide the specific information requested regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

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