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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.

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