(79 days)
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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.