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IR SLA Type 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. IR SLA Type Implant System is for one stage surgical procedures. It is intended for delayed loading. IR SLA Type Implant System is intended only for straight placement with no correction of angulation.

The IR SLA Type Implant System is a dental implant system made of CP Ti Gr 4, intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. 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 system has been treated with S.L.A.

The provided text does NOT describe an AI/ML powered medical device, therefore no information about acceptance criteria, study details, sample sizes, expert involvement, ground truth, or training sets is available as requested.

The document is a 510(k) premarket notification for a dental implant system (IR SLA Type Implant System), which is a physical medical device and not an AI/ML product. The document details the device's indications for use, description, comparison to predicate devices, and non-clinical testing performed to demonstrate substantial equivalence. These tests primarily cover material properties, sterilization, and biocompatibility, not AI model performance.

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