Search Results

The Lifecore Biomedical RENOVA™ Internal Hex Implant System is intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

The Lifecore Biomedical RENOVA Internal Hex Implant System consists of two-stage, rootform tapered and straight walled threaded dental implants and associated abutment systems, which provide the clinician with Screw-Retained (UCLA or Universal, Cement-on-Crown (COC), and Overdenture Snap Abutments. The system also includes surgical and restorative instrumentation: twist drills, surgical taps, surgical depth probe, depth gauges, abutment drivers, latch-type drivers, open end wrench, and hand-piece adapters. Lifecore RENOVA implants are available with a Resorbable Blast Media (RBM) roughened surface. All implants have an internal hexagon as a connection and as an anti-rotational feature for the prosthetics.

The provided text is a 510(k) summary for the RENOVA™ Internal Hex Implant System, which is a dental implant device. It is a regulatory submission demonstrating substantial equivalence to predicate devices, not a study that proves the device meets specific performance acceptance criteria through clinical trials or detailed technical investigations with quantitative metrics.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, and training set information cannot be extracted from this document, as it does not contain such details.

The document primarily focuses on:

• Device Description: What the device is and its components.
• Intended Use: The clinical applications for the device.
• Substantial Equivalence Comparison: How the device is similar to existing legally marketed devices, particularly regarding materials and design principles.
• Regulatory Classification: Its classification details.
• FDA Clearance: The letter from the FDA indicating clearance based on substantial equivalence.

There are no sections outlining specific performance metrics, clinical study designs, or analytical validations that would provide the detailed information requested about acceptance criteria and study results. This type of information is typically found in design verification and validation reports or clinical study reports, which are part of the larger 510(k) submission but are not typically included in the publicly available 510(k) summary.

Ask a specific question about this device