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The OsseoFuse Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

The OsseoFuse Dental Implant System includes Hexa-Plus S fixture, Hexa-Plus S abutment, and Hexa-Plus S Lab Components. This system made of Titanium intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. It 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 this system has been treated with R.B.M (Resorbable Blast Media).

The provided text is a 510(k) summary for the OsseoFuse Dental Implant System. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. However, it does not contain information about acceptance criteria, device performance metrics, or any clinical studies (retrospective, prospective, standalone, or comparative effectiveness) that would typically be conducted for a medical device that claims to meet specific performance criteria based on a study.

Instead, the submission relies on demonstrating substantial equivalence to a legally marketed predicate device (K110577, also named "OsseoFuse Dental Implant System" by KJ Meditech Co., Ltd.). The provided text explicitly states:

• "Based n a risk analysis of the modifications, no additional testing was added for this submission." (Page 3)
• "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." (Page 4)
• "When compared with predicate device, no new questions of safety or effectiveness have been raised." (Page 2)

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about a study, as such information is not present in the provided document. The basis for clearance is substantial equivalence, not a direct demonstration of performance against predefined acceptance criteria through new testing.

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