(32 days)
Restoration of deciduous teeth (especially class I) cavities
Not Found
The provided text is an FDA 510(k) clearance letter for a dental cement, "Ionofil Color AC". This type of document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
The letter's purpose is to inform the manufacturer that their device has been found substantially equivalent to a legally marketed predicate device, allowing them to market it. It discusses regulatory classifications, general controls, and compliance requirements, but not the technical details of the device's performance validation.
Therefore, I cannot provide the requested information based on the given text.
§ 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.