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USED AS A Composite RESTORATIVE to REPAIR CARIOUS LESIONS MATERÍAL FOR VENEERING. AND DoTASSIum CONTA

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I am sorry, but based on the provided text, there is no information about acceptance criteria for a device, a study that proves a device meets such criteria, or any of the detailed aspects like sample sizes, expert qualifications, or ground truth establishment.

The document is a 510(k) clearance letter from the FDA for a device named "Composite Restoration Material." This letter primarily addresses:

• Device Name: Composite Restoration Material
• Regulation Number/Name: 872.3690 / Tooth Shade Resin Material
• Regulatory Class: II
• Product Code: EBF
• FDA Determination: Substantially equivalent to legally marketed predicate devices.
• Conditions: The device can be marketed subject to general controls (registration, listing, GMP, labeling, etc.).
• Indications for Use: Used as a Composite Restorative to repair carious lesions, material for veneering.

This type of document confirms that the device is substantially equivalent to existing devices and can be marketed. It does not contain the results of a performance study with acceptance criteria, performance metrics, or details about the study design or data used to demonstrate those metrics. Therefore, I cannot provide the requested table or answer the specific questions about a study from the given text.

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