(48 days)
Miracle Mix is a powder and liquid self cure silver alloy glass ionomer cement intended for core build ups, restoration of primary teeth, as a base or a liner, for Class I, limited class II, temporary fillings and in cases where radiopacity is required.
Miracle Mix is a powder and liquid self cure silver alloy glass ionomer cement.
The provided document is a 510(k) premarket notification letter from the FDA regarding a dental product named "Miracle Mix Powder/Liquid." This document does not contain information about acceptance criteria or a study proving device performance in the way typically found for AI/ML medical devices.
Instead, this document is a regulatory approval letter stating that the device is substantially equivalent to legally marketed predicate devices, which allows it to proceed to market. It outlines the intended uses of the device and confirms its regulatory classification.
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth information, MRMC study details, etc.) from this specific document, as it is not a study report or clinical trial summary.
The document states:
- Device Name: Miracle Mix Powder/Liquid
- Indications for Use: Miracle Mix is a powder and liquid self cure silver alloy glass ionomer cement intended for core build ups, restoration of primary teeth, as a base or a liner, for Class I, limited class II, temporary fillings and in cases where radiopacity is required.
- Regulatory Class: II
This information is related to the product itself, not to a performance study for an AI/ML component.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.