(86 days)
Cimara:
- Intraoral repairs of defects in ceramic or composite veneer, fixed, prosthetic work with . metal frames.
Cimara Zircon: - Intraoral repairs of defects in ceramic veneer, fixed, all-ceramic restorations on . zirconium oxide frames and other oxide ceramics
- Intraoral repairs of fractures on ceramic and composite inlays .
Not Found
The provided text describes a 510(k) premarket notification for two dental devices, Cimara and Cimara Zircon, indicating their intended uses. However, it does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes, expert qualifications, ground truth establishment, or any other details that would allow me to answer the specific questions about the device's validation study.
The document is an FDA clearance letter, which confirms that the FDA has reviewed the submission and found the device substantially equivalent to legally marketed predicate devices. This letter does not typically include the detailed study results or the specific acceptance criteria met by the device. These details would typically be found in the 510(k) submission itself or in a summary of safety and effectiveness (SSE) if made publicly available.
Therefore, I cannot populate the table or answer questions 2 through 9 based on the provided text.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.