(138 days)
The UNO Narrow Implant is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by adjacent teeth and roots, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more Ø3.0 mm implants adjacent to one another. The UNO Narrow Implant is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.
The UNO Narrow Implant is a self tapping, root-form, two piece screw type dental implant, indicated for use in surgical and restorative applications for placement in the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. The UNO Narrow Implant is provided in one diameter (3 mm) in the following lengths: 10mm, 11.5 mm, 13mm and 16mm. The implants are tapered with double thread (2mm pitch) for fast insertion. The implants surface is sand blasted and acid etched. The UNO Narrow Implant is a two piece device whereas the implant is to be used in combination with replaceable ball attachments anchor screws and healing caps. The Uno implants and healing caps are supplied sterile and are intended for single use only. The ball attachment anchor screws are supplied non-sterile since immediately after their placement the ball attachments are used for impression coping in plastic materials. The UNO Narrow Implants are made of Ti6AL4V ELI complying with standard ASTM F 136-02- Standard Specification for Wrought Titanium-6Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant.
This document is a 510(k) summary for the UNO Narrow Implant, a dental device. It asserts substantial equivalence to a predicate device, the OsseoSpeed™ Narrow from Astra Tech AB. The summary does not describe an AI/ML device, nor does it present any studies or data related to AI/ML device performance. Therefore, I cannot provide the requested information about acceptance criteria or study details from this document.
The document discusses the following:
- Company Name: MIS Implants Technologies Ltd.
- Device Name: UNO Narrow Implant
- Predicate Device: OsseoSpeed™ Narrow from Astra Tech AB (K080396)
- Description of the device: Self-tapping, root-form, two-piece screw-type dental implant, made of Ti6AL4V ELI.
- Indications for Use: Placement in specific regions of partially edentulous jaws where horizontal space is limited, to support prosthetic devices.
- Substantial Equivalence: Claimed due to same intended use and equivalent performance characteristics, manufactured from the same Titanium alloy.
- Conclusion: The device is substantially equivalent to its predicate.
There is no mention of acceptance criteria, device performance metrics, sample sizes, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance studies, training sets, or how ground truth was established, as these are concepts relevant to AI/ML device testing, which is not applicable to this 510(k) submission.
§ 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.