(164 days)
For use in selected fully edentulous and partially edentulous arches
The additional components provided for by this 510(k) added to the fixtures, abutments and other components necessary to meet various clinical situations in partially and totally edentulous patients. All implants are root-form uncoated screws and are made from commercially pure titanium. The indications and uses for these additional components are not different from similar components of the predicate device. The application also provides for the use of the Single Tooth Implant System in multiple construction clinical situations.
This submission (K990304) is for additional components (abutments and fixtures) for an existing dental implant system, not a device that would typically have performance criteria measured by a clinical study with specific metrics like sensitivity, specificity, or accuracy. The FDA's review for this type of device focuses primarily on substantial equivalence to a predicate device, material safety, and mechanical integrity rather than diagnostic accuracy or clinical outcomes in the same way an AI/ML device would.
Therefore, the requested information regarding acceptance criteria, study details, expert review, MRMC studies, standalone performance, and ground truth for training and test sets is not applicable to this 510(k) submission.
This submission is a traditional 510(k) for an updated version of a previously approved device (K931767), comprising a list of components made of a known material (commercially pure titanium). The "acceptance criteria" in this context would revolve around demonstrating that the new components meet the same performance standards (e.g., mechanical strength, biocompatibility) as the predicate device and do not introduce new safety or effectiveness concerns. These kinds of evaluations are typically done through bench testing (e.g., fatigue testing, force retention, material characterization) rather than efficacy studies involving patient data and diagnostic performance metrics.
The documentation provided indicates that the "indications and uses for these additional components are not different from similar components of the predicate device." This suggests the primary "study" supporting the submission would be a demonstration of equivalence to the predicate, likely through design comparisons and perhaps limited bench testing for mechanical properties if the design significantly changed from the predicate.
§ 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.