Search Results

Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, and Legacy4 dental implants are two-piece 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.

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 (

The Legacy2, Legacy4, and simplyLegacy2 implants have implant body and are supplied in similar dimensions. This 510(k) notice includes the Legacy3 dimensions previously cleared in K090234 and K131097; the Legacy3 (7.0mmD) is the same as the previously cleared Legacy3, but in a wider diameter.

The top approximate one-third of the implant body is straight, and the lower approximate two-thirds is tapered with progressively deeper buttress-threads. The Legacy3 implant body also features progressively deeper buttress threads, with quadruple-lead micro-threads at the coronal aspect; this implant body is evenly tapered. Each implant features a color-coded internal hex with a lead-in bevel. The simplyLegacy2 and simplyLegacy3 implants are identical to the Legacy3 implants, respectively, except that they are supplied without the corresponding fixturemount/abutment.

The table below outlines the body diameters, platform diameters, and lengths in which each Legacy implant model is available.

The provided document is a 510(k) premarket notification from the FDA for dental implants. It details the device description, indications for use, comparison to predicate devices, and performance data. However, it does not contain information about a study proving that the device meets acceptance criteria related to an AI/ML-driven medical device, as implied by the detailed questions about ground truth, expert adjudication, MRMC studies, and training/test set sample sizes.

The performance data presented in the document solely pertains to physical and biological properties of the dental implants, such as fatigue testing, biocompatibility, surface area and bone-to-implant contact analysis, pull-out testing, insertion torque testing, sterilization validation, endotoxin testing, shelf-life validation, and distribution validation.

Therefore, I cannot answer the questions about acceptance criteria for an AI/ML device, ground truth establishment, sample sizes for AI/ML training/test sets, expert adjudication, or MRMC studies, as these concepts are not applicable to the content of this regulatory submission for traditional dental implants.

The document explicitly states on page 7: "No animal or clinical studies were performed in support of this 510(k) notice." This further confirms the absence of the type of studies implied by your questions, which are typically found in submissions for diagnostic or AI-powered devices.

Ask a specific question about this device