(60 days)
For cementing crowns, bridges, onlays, inlays and orthodontic bands.
Caution; US Federal Law restricts this device to sale by or on the order of a dental professional.
Labels will bear this caution.
AHL Generic Glass Ionomer Luting Cement
The provided text is a 510(k) premarket notification letter from the FDA for a dental cement. It does not contain information about the acceptance criteria and study proving device performance as requested. Such details would typically be found in the manufacturer's 510(k) submission, specifically sections related to performance data.
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.