(17 days)
The Sterngold Implant can be used in dental implant applications for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures.
Device consists of titanium screws, and titanium alloy prosthetics, brass and stainless steel restorative components, and stainless steel and titanium alloy surgical instruments.
I apologize, but the provided text is a 510(k) summary for a dental implant device and does not contain any information about acceptance criteria or a study that proves the device meets such criteria.
The document primarily focuses on:
- Device Description: What the device is made of and its components.
- Intended Use: How the device is meant to be used for oral rehabilitation.
- Technological Characteristics: How it compares to existing devices from the same company.
- Comparative Products: How it compares to similar products on the market.
- FDA Clearance Letter: Official communication from the FDA clearing the device for market based on substantial equivalence to predicate devices.
- Indications for Use: The specific medical conditions for which the device is intended.
Therefore, I cannot provide the requested table and information, as it is not present in the given text. This type of 510(k) summary, especially from 1998, typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study data with specific acceptance criteria and performance metrics.
§ 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.