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anaxBLEND:

• full or partial facing of fixed metal-based crowns and bridges;
• anterior and posterior crowns;
• inlays, onlays;
• facing of removable combined restorations (telescopic/conical crowns and attachment retained dentures);
• Characterization of dentures

anaxGUM:

• Esthetic rehabilitation of gingival parts in case of dental restorations with severe bone loss;
• Facing of the gingival area of removable combined restorations (telescopic/conical crowns and attachment-retained dentures);
• Characterization of dentures

mock-up direct / mock-up direct flow:

• mock-ups;
• direct anterior and posterior fillings of the classes 1, 11, 111, and V (Black);
• indirect restorations as inlays, onlays and veneers;
• extended fissure sealing of molars and premolars;
• core build-ups;
• splinting of loose teeth;
• shape and color corrections to improve the esthetic appearance

Not Found

The provided text is a 510(k) premarket notification letter from the FDA. It does not contain information about acceptance criteria or a study proving that a device meets those criteria.

Instead, this document:

• Identifies the device: anaxBLEND anaxGUM Mock-up direct / mock-up direct flow
• States its classification: Tooth Shade Resin Material, Regulatory Class: II, Product Code: EBF
• Confirms substantial equivalence to a predicate device, meaning it is considered as safe and effective as a legally marketed device.
• Outlines the indications for use for each product name (anaxBLEND, anaxGUM, mock-up direct / mock-up direct flow).

To answer your request, I would need a different type of document, such as a clinical study report, a performance testing report, or a summary of safety and effectiveness data that describes specific acceptance criteria and the results of a study designed to meet them.

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NEW OUTLINE is a resin used by dentists and dental technicians to fabricate temporary crowns and bridges.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding a dental device called "NEW OUTLINE," a temporary crown and bridge resin.

This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for AI/algorithm-based devices.

The letter is a regulatory approval document confirming substantial equivalence to a predicate device, which is a different type of assessment than what is typically requested for AI/machine learning device evaluations. It does not describe any studies involving algorithms or AI, nor does it provide performance metrics in the format of acceptance criteria or reported device performance.

Therefore, I cannot fulfill your request for the information outlined in your prompt based on the provided text.

Ask a specific question about this device