Search Results

The BTI System will be used to provide immediate or interim stability for new/existing dental prosthetics in partially or fully edentulous jaws.

Not Found

The provided text is a Food and Drug Administration (FDA) 510(k) premarket notification letter for the Bicon Transitional Implant (BTI) System. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain specific information regarding:

• Acceptance criteria for device performance
• Details of any study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance) that proves the device meets acceptance criteria.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This type of FDA clearance (510(k)) focuses on substantial equivalence to a predicate device rather than requiring extensive clinical trials or performance studies with detailed acceptance criteria as would be the case for a PMA (Premarket Approval Application) or De Novo classification for novel devices.

Therefore, I cannot provide the requested information from the given text.

Ask a specific question about this device