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Simply Iconic™ dental implants are two-piece implants for one-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.

Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

• Narrow (3.2mmD) implants: Indicated for single-tooth replacement (mandibular central and lateral incisors; maxillary lateral incisors), multiple-tooth replacements or denture stabilization.

· Short (6mm) 3.7mmD implants: Indicated for single-tooth (mandibular and maxillary central and lateral incisors), multiple tooth replacements or denture stabilization.

The Simply Iconic™ implants are two-piece dental implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.

The top one-third (coronal part) of the Simply Iconic™ implant body is straight, with quadruple-lead micro-threads on the coronal aspect, and the lower two-thirds is tapered with dual-lead progressively deeper buttress threads. This design is intended for increased bone-to-implant contact (BIC). Three cutting flutes extend over the tapered portion of the implant body to make bone tapping unnecessary for implant insertion.

The dental implant body are available in several diameter sizes (ranging from 3.2mmD - 7.0mmD), platform diameters (3.0, 3.4mmD) and lengths (ranging from 6 - 16 mm).

The Simply Iconic™ dental implants utilize the same implant abutment interface as the Implant Direct InterActive implants and are compatible with corresponding 3.0 and 3.4 mm platform InterActive abutments.

The Simply Iconic™ dental implants are composed of titanium 6AI4V ELI metal, anodized titanium 6Al4V ELI colors (magenta or gold). Soluble Blast Media (SBM) surface treatments with Hydroxyapatite (HA) blast media. SBM implant surfaces have a micro texture created on defined areas of the implant. The Simply Iconic™ dental implants are packaged sterile supplied with a cover screw and a 5mm healing collar.

The provided text is a 510(k) Summary for a dental implant device. It primarily details the comparison of the new device (Simply Iconic™ Implants) to predicate devices to establish substantial equivalence. It does not describe an AI/ML powered device, nor does it include information about acceptance criteria or studies related to AI/ML performance.

Therefore, I cannot fulfill the request as the document does not contain the required information for an AI/ML powered device, such as acceptance criteria tables, sample sizes for test/training sets, expert ground truth details, adjudication methods, or MRMC studies.

The document focuses on non-clinical testing for substantial equivalence of a physical dental implant, covering aspects like biocompatibility, fatigue, surface area analysis, pullout testing, insertion torque, sterilization, and shelf life.

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