(425 days)
Z-Look3 Dental Implants are suitable for all indications of endosseous implants in the upper and lower jaw, for the functional and aesthetic oral rehabilitation of edentulous and partially edentulous patients. The Z-Look3 Dental Implants with modifiable abutments are restored with fixed / cemented crowns and bridges. A special indication of the Z-Look3 Dental Implant System is for patients with metal allergies and chronic illnesses due to metal allergies.
Contraindications for the Z-Look3 Dental Implant Ø 3.25 mm:
- Restoration of posterior teeth in the upper or lower jaw
- Single-tooth restoration of canines and central incisors in the upper jaw
The Z-Look3 Dental Implant is a one-piece, self tapping, threaded, root form endosseous dental implant. Z-Look3 Dental Implants are offered in three diameters (3.25 mm, 4.0 mm, 5.0 mm) and four lengths (10 mm, 11.5 mm, 13.0 mm, 14.0 mm).
The provided text is a 510(k) summary for the Z-Look3 Dental Implant System. It describes the device, its intended use, and its equivalence to marketed devices. However, it does not contain information about acceptance criteria, specific studies proving the device meets those criteria, or details regarding performance evaluation studies such as sample sizes, ground truth establishment, or expert involvement.
The document states that the Z-Look3 Dental Implant System is "substantially equivalent in indications and design principles to predicate devices," implying that its performance is implicitly accepted based on the established safety and effectiveness of its predicates.
Therefore, I cannot provide the requested information. The text does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set, data provenance, or details about training sets.
- Number or qualifications of experts used to establish ground truth.
- Adjudication methods.
- Information about multi-reader multi-case (MRMC) comparative effectiveness studies or the effect size of AI assistance.
- Results from standalone (algorithm only) performance studies.
- The type of ground truth used.
- Sample size for the training set.
- How the ground truth for the training set was established.
The document primarily focuses on administrative information, device description, materials, and a declaration of substantial equivalence to predicate devices for regulatory clearance.
§ 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.