(33 days)
The cement is indicated for use in the cementing (luting) of a implant prosthesis.
The Steri-Oss Temporary Implant Cement serves as a cement for retention of implant prosthesis. The cement is a two part paste which is self cured on mixing and application. The product is provided in two 10 gram containers of polyalkylene material.
This document is a 510(k) summary for a dental cement. It does not contain any information about acceptance criteria or a study proving device performance against such criteria for AI/ML device.
The document states: "Performance Data... Not applicable, 510(k) requests a indication." This indicates that for this particular type of medical device (a dental cement), the submission requirements at the time did not necessitate extensive performance data beyond demonstrating substantial equivalence to a predicate device for its intended use.
Therefore, I cannot provide the requested information.
§ 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.