The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted.
The CR Abutment is an abutment placed over Neodent Zirconia Implants in order to provide support for prosthetic restorations, such as copings or crowns. It may be used for single-unit restorations that are cement-retained in esthetical areas over implants installed in maxilla or mandible.
- Intended for single use;
- Provided sterile via Ethylene Oxide;
- . All devices of Zirconia Implant System are manufactured of Y-TZP (Yttrium-stabilized zirconium dioxide);
- . The CR Abutment for Zirconia system is supplied along with a titanium alloy screw (ASTM F136);
- ZiLock prosthetic interface with internal indexer;
- Apically tapered implant with trapezoidal thread profile;
- Implant provided with sand-blasted, acid etched surface finish;
- . The subject Implants are compatible with the Zirconia Bases (already cleared per market per K201491) and CR Abutments (subject of this submission);
- . The subject CR Abutments are compatible with the Zirconia Implants 4.3 mm (already cleared per market per K201491) and Zirconia Implants 3.75 mm (subject of this submission).
This document describes the Neodent Implant System - Zirconia Implant System (K210336), which includes Zirconia Implants and CR Abutments. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly refer to "acceptance criteria" in the traditional sense of numerical thresholds for a study endpoint. Instead, the performance data presented aims to demonstrate equivalence to predicate devices through various tests.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 and ISO 10993-18. Not representing a new worst-case compared to K201491. | Biological Safety Assessment guided by ISO 10993-1 performed. Chemical characterization per ISO 10993-18 performed. Subject devices do not represent a new worst-case, relying on results from K201491. |
| Dynamic Fatigue Test | Equivalent fatigue strength to predicate devices per ISO 14801 and FDA Guidance. | Performed according to ISO 14801. Devices exhibit a level of performance equivalent to that reviewed for the predicate devices. SEM images after fatigue show similar wear to K201491. |
| Torsion Test | Sufficient resistance to static torsional loading. | Performed to evaluate the Zirconia Implant System under static torsional loading. (Specific quantitative results not provided in this summary). |
| Insertion Test | Acceptable insertion torque into different bone types. | Performed to evaluate insertion torque into sawbones material representing bone types I, II, III, and IV. (Specific quantitative results not provided in this summary). |
| Screw Torque Testing | No visible failure after torque application and removal. | Performed with torque application and visual analysis. No visible failure identified after applying torque and removing items. Subject screws considered equivalent to those cleared per K201491. |
| Sterilization Validation | Sterility Assurance Level (SAL) of 1x10^-6 via Ethylene Oxide (ISO 11135-1). Not representing a new worst-case compared to K201491. | Sterilized by Ethylene Oxide per ISO 11135-1 (over-kill method). Achieved an SAL of 1x10^-6. Subject devices do not represent a new worst-case, adopting the method from K201491. |
| Bacterial Endotoxin Testing | Results |
§ 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.