(143 days)
ITT dental implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges or overdentures in edentulous or partially edentulous patients.
The All-in-One implants are screw and cylinder type dental implants made from CP titanium, Grade 4. They are available in various diameters and insertion lengths. The implants have the same rough surface as cleared ITI endosseous implants. The transmucosal part has a smooth machined surface to allow for the attachment of epithelial tissue.
The provided text describes a 510(k) summary for the ITI Dental Implant System, which is a medical device submission to the FDA. This type of document is used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.
However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
The document primarily focuses on:
- Applicant and device identification.
- Declaration of substantial equivalence to previously cleared devices (K894593, K894595, K971578, K954512, K960288, K954347, K960417).
- Description of the device (materials, design, surfaces).
- Intended use (supporting crowns, bridges, or overdentures in edentulous or partially edentulous patients).
- FDA's response letter acknowledging the 510(k) submission and permitting market entry based on substantial equivalence.
Therefore, I cannot fulfill your request to describe acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.
For a 510(k) submission, the "proof" often comes from demonstrating that the device is substantially equivalent to a predicate device, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. While performance testing is usually conducted to support the substantial equivalence claim, the specifics of such tests (acceptance criteria, results, expert reviews, sample sizes) are not detailed here.
§ 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.