(85 days)
Bifix SE is intended for the following applications:
- permanent luting of inlays, onlays, crowns and bridges made from ceramic, composite and/or metal
- permanent luting of metal, ceramic and fibre-reinforced posts
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental cement (Bifix SE). It does not contain information about acceptance criteria, device performance from a study, sample sizes, expert qualifications, or details about a study design (MRMC, standalone, etc.) for an AI device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the given document.
§ 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.