(113 days)
The Klockner Essential implant system is especially designed for surgical insertion into the bone to replace the root of the teeth, acting as the support for the dental implants formed by implant accessories.
The Essential Cone 1.5 implants are fitted with an internal octagonal conical connection. Immediate loading is appropriate for the Essential Cone 1.5 implants when good primary stability is achieved with appropriate occlusal loading.
8mm Implants are not indicated for use as single implants and for immediate load.
The Klockner Essential Cone 1.5 implant system consists of a implants to restore the mastication system. The different EC 1.5 are available in four different diameters: 3.5mm, 4.0mm, 4.5mm and 4.8mm and the range of lengths varies between 8mm and 16mm. They are internally connected.
I am sorry but the provided text describes a 510(k) premarket notification for a dental implant system (Klockner Essential Implant System Models Essential Cone 1.5). This type of document focuses on establishing substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance data often found in clinical trials or AI/software validation studies.
Therefore, I cannot extract the information required concerning acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The document primarily states that the device is "substantially equivalent to the previously cleared Klockner Essential Cone (EC) dental implants system cleared in K080224 because the intended use, the composition and the endosseous surface treatment are identical to the Klockner Essential predicate devices. The design principles are the same as the Klockner Essential predicate devices." This means the product is considered safe and effective based on its similarity to an already approved device, not on a new, explicit performance study against defined acceptance criteria.
§ 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.