(151 days)
BeautiCem SA is intended for cementation of dental restorations, dental restorative materials and prostheses to intraoral hard tissues, specifically intended for cementation of restorations (inlays, onlays, crowns, bridges, etc.) made of metal, ceramics (porcelain, alumina, or zirconia) or resin material to natural teeth. BeautiCem SA is also intended for cementation of indirectly prepared metal-core or resin-core to natural teeth.
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The provided text is a 510(k) premarket notification letter from the FDA to Shofu Dental Corporation regarding a dental cement product called BEAUTICEM SA. It confirms the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements.
However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment. This type of information is typically found in the 510(k) submission itself, not in the FDA's clearance letter. The letter primarily states the regulatory decision and relevant compliance information.
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.