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Indications for Use: Miracle Mix is a self cure silver alloy glass ionomer cement intended for use as a dental restorative available in premeasured single use capsules.

Miracle Mix is a self cure silver alloy glass ionomer cement intended for use as a dental restorative available in premeasured single use capsules.

This document is a 510(k) clearance letter from the FDA for a dental restorative device called "Miracle Mix Capsule Modification." It signifies that the device is substantially equivalent to a predicate device already on the market.

However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The letter primarily focuses on:

• Device Identification: Miracle Mix Capsule Modification
• Regulatory Classification: Class II
• Product Code: EMA
• Date of Clearance: June 1, 1998
• Indications for Use: "Miracle Mix is a self cure silver alloy glass ionomer cement intended for use as a dental restorative available in premeasured single use capsules."
• General Controls: The device is subject to general controls provisions of the Act, including annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

Therefore, I cannot provide the requested table and information as the source document does not contain this type of data.

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