(476 days)
Tizian Blank Zirconia Reinforced Composite is made of a composite material reinforced with zirconium dioxide. The blanks can be processed with CAD/CAM technology. Optionally, the blanks can be veneered with a composite or with a monolithic material. Applications are:
- long-term temporaries (for up to 2 years)
- up to 16-unit anterior and posterior crowns and bridges, fully anatomic or reduced
- only up to 2 bridge units in the posterior sector
- free-end bridges with no more than one attachment
- small permanent restorations (those must be veneered with an incisal material)
- individual crowns
- inlays
- onlays
- veneers
- bridges with a maximum of 3 units.
Tizian Blank Zirconia Reinforced Composite is made of a composite material reinforced with zirconium dioxide. The blanks can be processed with CAD/CAM technology. Optionally, the blanks can be veneered with a composite or with a monolithic material.
This document is a 510(k) premarket notification for a dental device, specifically "Tizian Blank Zirconia Reinforced Composite." It does not contain information about acceptance criteria or a study proving device performance in the context of AI/ML or diagnostic accuracy. Instead, it is an FDA letter confirming substantial equivalence to a predicate device for market clearance.
Therefore, I cannot provide the requested information based on the provided text. The document is strictly related to regulatory clearance for a physical dental product, not a software or AI/ML device that would typically undergo performance studies with acceptance criteria as described in your prompt.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.