(88 days)
The cement is indicated for use in the cementing (luting) of a implant prosthesis.
Steri-Oss Until . Implant Cement is indicated_ for .... cementing (luting) of a implant prosthesis.
The Steri-Oss Until Implant Cement serves as a cement for retention of armund on mixing cement serves as a cement roll - that is self cured on mixing The cement is a cwo pars pars provided in two 10 gram containers of polyalkylene material.
The provided text is a 510(k) submission for the Steri-Oss Until Implant Cement. It details the device's description, intended use, and comparison to a predicate device for substantial equivalence. However, this document does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria.
Therefore, I cannot provide the requested information from the given input. The 510(k) summary focuses on demonstrating equivalence to a predicate device rather than presenting performance data against predefined acceptance criteria from a specific study.
§ 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.