(94 days)
Provicol QM Plus is intended for use as:
- · Temporary cementation of provisional restorations (crowns, bridges, inlays and onlays)
- . Temporary cementation of definitive restorations (crowns, bridges, inlays and onlays)
Not Found
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. The document is an FDA letter regarding a 510(k) premarket notification for a dental cement called "Provicol QM Plus." It states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements for the manufacturer. It also includes the indications for use statement for the device.
Therefore, I cannot provide the requested information, including the table of acceptance criteria, sample sizes, expert qualifications, study types, or ground truth details, as this information is not present in the given 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.