(61 days)
Temporary fillings of Class I and II cavities.
Temporary sealing in endodontics.
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets specific acceptance criteria.
The document is a clearance letter from the FDA for a device called "Coltosol F." It states that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It also mentions the indications for use. However, it does not detail any performance metrics, studies, or acceptance criteria in the context of device performance.
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.