(21 days)
The Implant for dental purposes, used to replace missing dental organs (teeth). The Implant is self-tapping (threads) and is screwed into a pilot bore formed in the jawbone. Upon healing, the Implant receives a post, which has a stem, and is adapted to carry dental suprastructures (false teeth).
The BASIC Dental Implant is an endosseous dental implant.
The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria.
Specifically:
- Acceptance Criteria and Reported Device Performance: The document explicitly states "Performance Data: None" and "Results of Clinical Study: None." Therefore, no table can be created.
- Sample Size and Data Provenance (Test Set): Not applicable, as no study results are reported.
- Number and Qualifications of Experts (Ground Truth - Test Set): Not applicable.
- Adjudication Method (Test Set): Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable, as no study is detailed.
- Standalone Performance Study: Not applicable.
- Type of Ground Truth Used: Not applicable.
- Sample Size for Training Set: Not applicable.
- How Ground Truth for Training Set was Established: Not applicable.
The document is a 510(k) summary for the BASIC Dental Implant System Implant. It focuses on demonstrating substantial equivalence to a legally marketed predicate device (BASIC Dental Implant System, K960868), which allowed it to be marketed without new clinical performance data. The FDA letter confirms the substantial equivalence determination.
§ 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.