(293 days)
Z5c implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. Z5c implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them. Z5c implants are intended for delayed loading.
Z5c is a two-piece, root-form, threaded implant and abutment system made from yttria-stabilized zirconia (Y-TZP). The Z5c implant endosseous surface is grit blasted and laser modified. The Z5c implant and corresponding abutment are bonded together using a self-adhesive resin cement. The Z5c implant system is designed for single or multiple tooth restorations. Z5c implants are provided in two endosseous diameters (4.0 and 5.0 mm) and each diameter is provided in three lengths (8, 10, and 12 mm). Z5c abutments are provided in two designs, straight and angled 15°.
The Z5c dental implant device underwent non-clinical and clinical testing to demonstrate substantial equivalence to predicate devices, thus meeting acceptance criteria for market authorization.
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance |
|---|---|
| Same intended use | Z5c implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth, and are suitable for patients with metal allergies and chronic diseases resulting from them. This is consistent with predicate devices. |
| Same operating principle | The device functions as an endosseous dental implant system, consistent with predicate devices. |
| Basic design coherence | Z5c is a two-piece, root-form, threaded implant and abutment system. This is consistent with various predicate devices, which include one-piece and two-piece designs. |
| Similar materials | Z5c is made from yttria-stabilized zirconia (Y-TZP). Predicate devices utilize zirconia and/or titanium for implants and abutments. |
| Similar packaging and sterilization | The submission states similar packaging and sterilization methods are used as predicate devices. |
| Similar range of physical dimensions and characteristics (implant diameter, length, surface treatment) | Implant Diameter: Z5c: 4.0 - 5.0 mm. Predicates: range from 3.3 - 6.0 mm, with some not applicable. |
| Implant Length: Z5c: 8 - 12 mm. Predicates: range from 8 - 16 mm, with some not applicable. | |
| Implant Surface: Z5c: Grit blasted and laser modified. Predicates: Grit blasted and laser modified, TiUnite®, Grit blasted and acid etched. | |
| Static and dynamic compression-bending testing (ISO 14801) | Fatigue testing in a saline environment demonstrated the subject device to be equivalent to the predicate devices. |
| Clinic placement, loading, and follow-up data | A summary of clinical placement, loading, follow-up data was provided, along with multiple clinical case reports. |
2. Sample Size and Data Provenance (Test Set):
The document does not explicitly state a specific sample size for a "test set" in the context of an AI/algorithm-driven device evaluation. Instead, the evaluation for this dental implant relies on:
- Non-clinical testing data: This includes engineering analysis, dimensional analysis, and static and dynamic compression-bending testing according to ISO 14801. The number of samples for each test type is not specified in the summary.
- Clinical data: A summary of clinical placement, loading, follow-up data, and multiple clinical case reports were submitted. The total number of patients or implants included in this clinical data is not specified.
- Data Provenance: Not explicitly stated, however, the manufacturer is Z-Systems AG, Switzerland. Given the context of a 510(k) submission to the FDA, it is likely that the data were collected in accordance with international standards, but specific countries of origin for the clinical data are not mentioned. The data is presented as if it is retrospective compilation (summary of placement, follow-up, and case reports) rather than a prospective, controlled trial for this specific submission.
3. Number of Experts and Qualifications (Test Set Ground Truth):
Not applicable in the context of this traditional medical device submission. Ground truth for dental implants is typically established through objective measures (e.g., successful osseointegration, absence of complications, mechanical integrity) validated by clinical outcomes and engineering specifications, rather than expert consensus on image interpretation.
4. Adjudication Method (Test Set):
Not applicable. The evaluation is based on engineering tests and clinical outcomes, not interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not an AI-assisted diagnostic device. The evaluation focuses on the physical and biological performance of the implant.
6. Standalone (Algorithm Only) Performance:
Not applicable. This is a physical medical device (dental implant), not an algorithm.
7. Type of Ground Truth Used:
- Engineering Specifications: Compliance with ISO 14801 for mechanical properties (fatigue strength).
- Clinical Outcomes/Performance: Successful placement, loading, and follow-up data indicating the implant's ability to replace missing teeth without significant complications. This would implicitly involve aspects like osseointegration, stability, and lack of adverse events.
- Material Science: Demonstrating the yttria-stabilized zirconia (Y-TZP) material meets relevant standards and is suitable for implantation.
8. Sample Size for Training Set:
Not applicable. This is a physical medical device. There is no AI model or algorithm requiring a training set.
9. How Ground Truth for Training Set Was Established:
Not applicable (as above).
§ 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.