(42 days)
Provisional dental cement for the temporary fixation of:
- temporary crowns and bridges
- temporary inlays and onlays
- definite restorations
PROCEM® is classified as a dental cement other than zinc oxide-eugenol (21 C.F.R. § 872.3275) because it is a eugenol-free dental cement intended to be used for temporary fixations of crowns, bridges, inlays, and onlays.
This looks like a 510(k) premarket notification for a dental cement called PROCEM®. The document indicates that this is a traditional medical device, not an AI/ML medical device. Therefore, a study demonstrating AI/ML performance metrics such as acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies would not be relevant or present in this type of submission.
The document primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, function, and chemical composition (with biocompatibility data provided for a new component).
Therefore, I cannot provide the requested information as it is not applicable to this submission.
§ 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.