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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:

1. 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

2. 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.

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Tizian Ceramic is a glass ceramic material, colored to match the VITAPAN® color system. It is used for the ceramic coating of titanium and titanium alloys as well as zirconium dioxide-based frame materials.

Tizian Zr Blanks are produced of yttrium oxide-stabilized tetragonal zirconium dioxide in several different sizes for the production of full ceramic crowns, bridges and inlays.

Tizian Ceramic is a glass ceramic material, colored to match the VITAPAN® color system. It is used for the ceramic coating of titanium and titanium alloys as well as zirconium dioxide-based frame materials. Tizian guarantees an easy and reliable treatment without the need for long-term cooling.

Tizian Blanks are composed of tetragonal zirconium dioxide stabilized with yttrium oxide. They are available in different sizes and permit the production of ceramic crowns and bridges. The material is partially sintered and can be processed using copy milling as well as CAD/CAM procedures.

This document is a 510(k) Premarket Notification summary for "Tizian Ceramic" and "Tizian Zr Blanks." It describes the materials and their intended use, and indicates FDA clearance. However, it does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance metrics.

Therefore, I cannot provide the requested table and information as the provided text lacks the necessary details. The document is primarily a regulatory submission for market clearance based on substantial equivalence to predicate devices, not a performance study report.

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Cold-curing, methyl methacrylate resin for adding the saddles to cobalt chrome denture bases, repairs, additions and relines, and relines. Cold-curing, methyl methacrylate resin for the completion of full and partial dentures. Cold-curing, methyl methacrylate resin for adding saddles to cobalt chrome dentures bases, repairs, additions and other repairs. Cold-curing, methyl methacrylate resin intended specifically for injection moulding techniques (e. g. Unipress). Cold-curing repair resin for additions, replacing teeth and relining dentures. Heat-curing, methyl methacrylate resin for fabricating partial and full dentures using flasks and clamps or injection moulding systems. Heat-curing, methyl methacrylate resin, with liquid phase, for adding the saddles to cobalt chrome denture bases and other repairs.

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I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for several dental resins. It confirms that the devices are substantially equivalent to legally marketed predicate devices.

The document does not contain any information about:

• Acceptance criteria table or reported device performance for a study.
• Sample sizes used for test sets or data provenance.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone (algorithm only) performance studies.
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training sets was established.

Therefore, I cannot fulfill your request for this information based on the provided text.

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ReVeneer is an intraoral and extraoral repair system for ceramic crown and bridge veneers with the following advantages:

• no acid etching (neither hydrofluoric nor phosphoric acid)
• safe intraoral use
• extremely good bond strength
• time saving
• can be used universally, with all conventional ceramics
• use of conventional curing lights (halogen, LED, plasma)

ReVeneer Ceramic Repair System with the following components:

1. Primer
2. Base
3. Opaquer (light and dark)
4. Composite Fillis

The requested information is not available in the provided text. The document is a 510(k) summary for a "ReVeneer Ceramic Repair System" and contains administrative and regulatory information, but no details about acceptance criteria or a study proving device performance are present.

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Sebond Pink: Paste opaquer with integrated metal-resin bonding system, for framework retention (no additional bonder necessary)
Sebond Smart: Odorless metal primer, universally suitable for all metals, guarantees a lasting bond.
Sebond Grip: Increases the bond (in combination with a metal primer, e. g. Sebond Smart) between metal and opaquer, for more safety and less spalling.

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The provided text is a 510(k) summary from the FDA for a dental bonding agent. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The document only states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information.

Ask a specific question about this device