Search Results

CFS FLEXIBLE™ is a break resistant material used in the fabrication and repair of base plates for removable dental prosthetic appliances where superior flexibility and patient comfort for the lifetime of the prosthetic are significant concerns. This includes, but not limited to, full and partial dentures, orthodontic devices, occlusal splints, and night guards.

CFS FLEXIBLE™ is an injection moldable, flexible, thermoplastic nylon with trace amount of colorant added. CFS FLEXIBLE™ is used for fabricating removable dental prosthetic appliances such as in and partial dentures, orthodontics devices, occlusal splints and night guards both permanent and temporary. Because it can be used to create completely non-metallic prosthetics, it is perfect for making removable dental prosthetic appliances for metal-allergic patients.

The provided text, K0815537, describes a 510(k) premarket notification for a dental device called CFS FLEXIBLE™. However, the document does not contain the specific information required to answer your questions regarding acceptance criteria and a study proving the device meets those criteria.

This 510(k) summary is primarily focused on establishing substantial equivalence to an existing predicate device (TCS® Unbreakable, cleared under K0530160), rather than detailing specific performance studies with acceptance criteria for the new device.

Here's why the requested information is missing:

• Acceptance Criteria and Device Performance: The document states, "CFS FLEXIBLE™ is safe: and effective as the predicate device cited above." It does not provide a table of acceptance criteria or specific performance metrics for CFS FLEXIBLE™ itself. The basis for safety and effectiveness is simply its similarity to the predicate.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth): Since the 510(k) focuses on substantial equivalence based on the predicate device's existing clearance, it typically doesn't include detailed performance studies with sample sizes, expert involvement, or adjudication methods for the new device. Such studies are usually required for novel devices or when significant differences from a predicate demand new performance data.
• Training Set Information: As no specific performance study is detailed, there's no mention of a training set or how its ground truth was established.

In summary, the provided document does not contain the information requested in your prompt because it is a 510(k) summary primarily demonstrating substantial equivalence to a predicate device, rather than a detailed report of a performance study with acceptance criteria for the new device.

Ask a specific question about this device