(87 days)
Bosworth AEGIS Liner & Restorative Material is used as a light-cured radio-opaque cavity liner and pulp capping material, and, with the addition of tooth shades, as a class V restorative material.
AEGIS Liner & Restorative Material w/ACP
The provided text is a Section 510(k) premarket notification determination letter from the FDA for a dental device, "AEGIS Liner & Restorative Material w/ACP."
This document does not contain any information regarding acceptance criteria or a study proving that the device meets those criteria.
The letter's purpose is to inform the manufacturer that the FDA has reviewed their submission and determined the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on the information provided by the manufacturer in their original 510(k) submission, which would have included performance data, but that data is not present in this FDA letter.
Therefore, I cannot answer any of the specific questions about acceptance criteria or study details as they are not described in the provided 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.