(56 days)
SpeedCem is indicated fo rthe Permanent cementation of indirect restorations made of:
- metal and metal-ceramic (inlays, onlays, crowns, bridges, endodontic posts)
- high-strength all-ceramic: zirconium oxide, lithium disilicate and aluminium oxide ceramics
- (crowns, bridges, endodontic posts)
- fibre-reinforced composite (endodontic posts)
Not Found
I apologize, but the provided text is a 510(k) premarket notification letter for a dental cement called SPEEDCEM. It discusses the regulatory review process and confirms the device's substantial equivalence to other legally marketed predicate devices.
The document does not contain any information about acceptance criteria, study details, performance data, sample sizes, expert qualifications, or ground truth establishment for a medical device's performance.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.
§ 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.