(86 days)
Multilink® is a self-curing and self-etching luting composite system for the adhesive whiles is a coll cannons made of metal, metal-ceramic, all-ceramic and composite.
It is Contraindicated if the patient has allergies to any ingredient; and no direct application on pulpa-near dentin or on the open pulp or irritations of the pulp may occur.
Multilink® is a self-curing and self-etching luting composite system
I am sorry, but the provided text from the FDA 510(k) summary for the Multilink device (K032470) does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance.
The document is a clearance letter from the FDA to Ivoclar Vivadent, Inc., confirming that their Multilink dental cement is substantially equivalent to legally marketed predicate devices. It primarily focuses on regulatory approval, classification, and general controls provisions of the Federal Food, Drug, and Cosmetic Act.
The document does not include:
- A table of acceptance criteria and reported device performance.
- Details about a study with sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- Training set sample sizes or how their ground truth was established.
Therefore, I cannot provide the requested information based on the input 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.