(20 days)
ITI implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. ITI Dental Implants are for single-stage or two-stage surgery. ITI Dental Implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used.
The ITI Standard PLUS implants are modifications of the currently distributed ITI Esthetic PLUS implants. The subject implant is a solid screw with an SLA surface (grit blasted then acid etched). The implants are composed of Grade 4 commercially pure titanium and are available in a range of lengths and diameters.
The provided submission describes a medical device, the ITI® DENTAL IMPLANT SYSTEM (Standard PLUS implants), and its substantial equivalence to a predicate device. However, it does not contain any information regarding specific acceptance criteria, performance studies, or clinical trial data.
The document K033922 is a 510(k) summary for a premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing de novo clinical efficacy or performance data against pre-defined acceptance criteria.
Therefore, I cannot provide the requested information. The document focuses on:
- Device Description: The ITI Standard PLUS implants are modifications of already distributed ITI Esthetic PLUS implants. They are solid screw implants with an SLA surface, made of Grade 4 commercially pure titanium, and available in various lengths and diameters.
- Intended Use: Surgically placed in maxillary/mandibular arches to support prosthetic restorations in edentulous or partially edentulous patients, for single-stage or two-stage surgery. Intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading.
- Substantial Equivalence: The key argument for market clearance is that the device is substantially equivalent to the previously cleared ITI Esthetic PLUS implants (K983742 and K030007) due to identical intended use, material composition, surface treatment, and almost identical design.
In summary, none of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is present in the provided text. This type of information is typically part of a robust clinical study report, which is not included in this 510(k) summary.
§ 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.