(77 days)
The Bicon Two Part Abutment is designed for use in the mandible or maxilla for the support of a terminal or intermediate crown for fixed bridgework or for a single tooth crown.
Two Part Abutment System
This document is a 510(k) clearance letter from the FDA for a dental implant product (Bicon Dental Implants Two Part Abutment System). It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this type of FDA clearance letter does not contain the detailed information about acceptance criteria, specific device performance studies, sample sizes, ground truth establishment, or expert qualifications that you are requesting.
A 510(k) clearance primarily focuses on demonstrating substantial equivalence to a predicate device, meaning it has the same intended use and technological characteristics as a device already on the market, or if there are differences, those differences do not raise new questions of safety and effectiveness.
To find the information you are looking for (acceptance criteria, study details, etc.), you would typically need to refer to:
- The actual 510(k) submission document: This is a much more extensive document submitted by the manufacturer to the FDA, detailing all the testing and data. These are often not publicly available in their entirety, though summaries (like the FDA's "Summary of Safety and Effectiveness" or "510(k) Premarket Notification") might be.
- Published scientific literature: Manufacturers often publish studies related to their devices in peer-reviewed journals.
- Manufacturer's technical documentation: Information provided directly by Bicon, Incorporated for their device.
Therefore, based solely on the provided text, I cannot answer your specific questions. The text only states that the device is substantially equivalent to predicate devices for its intended use, which is for supporting crowns in the mandible or maxilla.
§ 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.