(89 days)
The XiVE® Transgingival Dental Implant System is indicated for single-stage implant placement, with a minimum healing phase of three months in good quality bone and four months in spongy bone, for maxillary and mandibular splinted crowns. bridges and bar-retained overdenture restorations. The bridge must be supported by a minimum of two transgingival threaded implants.
In the edentulous maxilla, a minimum of four transgingival implants are placed in a trapezoidal distribution and rigidly splinted together.
In the edentulous mandible, a minimum of four transgingival implants ≥ 9.5mm are placed between the mental foramina and rigidly splinted together. In this case, bar-prosthetic loading is possible immediately after implant placement.
The XiVE® Transgingival Dental Implant System consists of transgingival threaded dental implants in 3.4 - 5.5mm diameters with 8 -- 18mm lengths. The implants are coated with the FRIOS Deep Profile Surface. The XiVE® Transgingival Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for single stage procedures for single tooth replacement, fixation of bridges and complete dentures and for immediate loading indications in the edentulous mandible.
This document is a 510(k) premarket notification for a dental implant system. It describes the device, its intended use, and its substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
Based on the provided text, the dental implant system is being cleared through the 510(k) pathway by demonstrating substantial equivalence to predicate devices, rather than through a study demonstrating direct performance against specific acceptance criteria.
Therefore, I cannot provide the requested information for the following reasons:
- No Acceptance Criteria or Reported Device Performance: The document does not specify any quantitative acceptance criteria for device performance (e.g., success rates, failure rates, stability measurements) or report any performance data from a study.
- No Study Described: The submission relies on substantial equivalence to predicate devices (FRIALOC® Dental Implant System K013067 and XiVE® Dental Implant System K013867) rather than a new study to prove specific performance metrics. The information provided does not describe a clinical or non-clinical study designed to test the device's performance against acceptance criteria.
- No Information on Sample Sizes, Experts, Adjudication, MRMC, or Standalone Performance: Since no performance study is described, there is no mention of these elements.
- No Ground Truth Information: Without a study to establish performance, there is no discussion of how ground truth would be established for such a study.
The core of this 510(k) submission is the claim of substantial equivalence in "design, materials, coatings, mechanical strength, and intended use" to previously cleared devices (for FRIALOC®) and "materials, coatings, prosthetic options, and intended use" (for the existing XiVE® system). The FDA's clearance letter confirms this substantial equivalence determination, allowing the device to be marketed.
§ 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.