Search Results

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.

Ask a specific question about this device