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The Kerator fixture is intended for use in partially or fully edentulous mandibles and maxillae, in support of multiple-unit restorations. The Kerator abutments are intended use with overdentures or partial dentures. Kerator AO type is compatible with Kerator fixture and the following types are compatible with the fixtures made by other manufacturers as indicated below.

The Kerator is a dental implant system made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. There are one fixture model and three abutment models in the Kerator. Among three abutment model is compatible with the Kerator fixture, and the other two abutment models are compatible with the fixtures made by other manufacturers. The implant may be used to replace one or more missing teeth. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of the fixture has been treated with R.B.M (Resorbable Blast Media) and the head part of the abutment has TiN coating over it. The Kerator abutment is placed into the dental implant to provide support for a prosthetic restoration.

The Kerator system is a dental implant system. The provided text describes the device and its equivalence to predicate devices, but it does not contain any information about a study with acceptance criteria and reported device performance in relation to AI or any advanced analytical methods.

Therefore, I cannot provide the requested information in the format of the table or other points, as the document focuses on regulatory approval based on substantial equivalence to existing devices, primarily through material and design comparisons and standard non-clinical testing (sterilization, shelf life, chemical analysis). It does not involve AI or algorithms, nor does it present clinical performance data against specific acceptance criteria in the manner described in your prompt.

The document indicates "Non-Clinical Testing" for sterilization, shelf life, and chemical/SEM analysis, which are standard safety and manufacturing validations, not performance against clinical or analytical acceptance criteria.

If the prompt were referring to a different type of device or study that typically involves such criteria, the answer would differ. However, based solely on the provided text, there is no such study or acceptance criteria information to extract.

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