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Nobel Biocare's NobelPerfect Conical Connection implants are endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The NobelPerfect Conical Connection implants are indicated for single or multiple unit restorations. The NobelPerfect Conical Connection implants can be used in splinted or non-splinted applications. The NobelPerfect Tapered Conical Connection implant may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.
Nobel Biocare's NobelPerfect Conical Connection implants are threaded, root-form dental implants intered for use in the upper and lower jaw arches to support prosthetic devices, such as an artificial tooth, in order to restore esthetics and chewing function to partially or fully edentulous patients.
The NobelPerfect Conical Connection implants are similar in design to the NobelPerfect Groovy implants cleared under "Groovy Implants" (K050258). Like the NobelPerfect Groovy implant, the NobelPerfect Conical Connection implant is machined from commercially pure titanium, grade 4, have a tapered body Onlival Onlinedian implant is machines nother the body, and a TiUnite "sufface treatment. The difference between the two implants is that the NobelPerfect Conical Connection implants have the same internal conical connection as the SFB implants, cleared under "SFB & CFB Implants"(K061003).
This document is related to a 510(k) premarket notification for a dental implant, the NobelPerfect Conical Connection. It describes the device, its indications for use, and a letter from the FDA stating its substantial equivalence to predicate devices.
The document does not contain information about acceptance criteria, device performance testing, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment. This type of information is typically found in engineering reports, clinical study summaries, or validation reports, which are usually separate from the 510(k) summary and FDA clearance letter provided here.
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§ 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.