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• Class I to V restorations
• Base in class I and II cavities
• Reconstruction of traumatically damaged anteriors
• Facetting of discoloured anteriors
• Correction of shape and shade for improved aesthetic appearance
• Locking, splinting of loose teeth
• Repairing veneers, small enamel defects and temporary C&B-materials
• Extended fissure sealing
• Restoration of deciduous teeth
• Core build-up
• Composite inlays

Not Found

This is an FDA clearance letter for a dental material (Admira Fusion 5), not a medical device that uses AI or requires a study with specific acceptance criteria related to algorithm performance. Therefore, the provided text does not contain the information needed to answer the questions about acceptance criteria, study design, ground truth, or expert involvement as described in your prompt.

The document is a 510(k) premarket notification clearance letter, which confirms that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory requirements for dental materials.

To answer your questions, I would need a document that describes the clinical performance or validation study of a specific medical device, especially one involving an AI algorithm.

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• Base in class I and II cavities
• Cavity lining under direct restorative materials in class I and II cavities
• Small, non occlusal stress-bearing class I restorations according to minimally invasive filling therapy
• Class III and V restorations
• Extended fissure sealing
• Undercut blockout
• Repair of small enamel defects
• Repair of small defects in aesthetic indirect restorations
• Repair of temporary C&B-materials
• Core build-up

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to VOCO GmbH regarding their device, Admira Fusion x-base. This document is a regulatory approval letter and an "Indications for Use Statement." It does not contain information about acceptance criteria, study methodologies, device performance data, sample sizes, or expert qualifications for testing.

Therefore, I cannot provide the requested information based on the input text. The document confirms the device's classification and lists its intended uses but does not detail the studies or data used to support its safety and effectiveness.

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Admira Fusion Flow is intended for use as:

• Filling of small cavities and extended fissure sealing
• Blocking out undercuts
• Lining or coating cavities
• Fillings of class III V cavities
• Repairing fillings, veneers and temporary restorations
• Luting translucent prosthetic pieces
• Locking, splinting of loose teeth

Not Found

The provided text is a 510(k) summary for a dental device (Admira Fusion Flow) and does not contain information about acceptance criteria or a study proving its performance against such criteria. The document is an FDA clearance letter confirming substantial equivalence to a predicate device, along with the device's indications for use.

Therefore, I cannot extract the requested information regarding acceptance criteria and performance study details from this document.

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Admira Fusion x-tra is intended for use as: - Class I and II posterior restorations - Base in class I and II cavities - Class V restorations - Locking, splinting of loose anteriors - Repairing veneers, small enamel defects and temporary C&B-materials - Extended fissure sealing - Restoration of deciduous teeth - Core build-up

Not Found

The provided text is a 510(k) clearance letter from the FDA for a dental resin material. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. Such details would typically be found in the 510(k) submission document itself, not in the clearance letter.

Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device

Admira Fusion is intended for use as:

• Class I to V restorations
• Base in class I and II cavities
• Reconstruction of traumatically damaged anteriors
• Facetting of discoloured anteriors
• Correction of shape and shade for improved aesthetic appearance
• Locking, splinting of loose anteriors
• Repairing veneers, small enamel defects and temporary C&B-materials
• Extended fissure sealing
• Restoration of deciduous teeth
• Core build-up
• Composite inlays

Not Found

I am sorry, but this document contains no information about the acceptance criteria or a study proving that the device meets them. This document is a 510(k) clearance letter from the FDA for a dental resin product called "Admira Fusion". It primarily communicates that the device has been found substantially equivalent to predicate devices and outlines regulatory obligations.

Ask a specific question about this device