(179 days)
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MILO™ Implants are indicated for long-term maxillary and mandibular tissuesupported denture stabilization. Multiple implants may be restored after a period of time or placed in immediate function.
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MILO™ Implants are indicated for the rehabilitation of single and/or multiple maxillary lateral incisors. They are also indicated for the rehabilitation of single and/or multiple mandibular central and lateral incisors. The implants may be restored after a period of time or placed in immediate function.
The Intra-Lock MILO™ Dental Implant System consists of machined titanium, screw-form dental implants 3.0mm in diameter. They are available in lengths of 10mm, 11.5mm, 13mm and 15mm. The implants' raw material is Titanium Alloy for Surgical Implant Applications (as per ASTM F 136 Standard Specification for Wrought Titanium-6Aluminium-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS) R56401). The implants are sterile packaged.
The provided text is a 510(k) summary for a dental implant system (Intra-Lock MILO™ Implant) and does not contain information about acceptance criteria, device performance, or a study proving that the device meets acceptance criteria.
The 510(k) summary focuses on establishing substantial equivalence to predicate devices, providing a device description, intended use, and the FDA's clearance letter. It does not include the details typically found in a clinical study report or performance testing document that would describe acceptance criteria and how they were met.
Therefore, I cannot provide the requested information based on the provided text.
§ 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.