(49 days)
GVC-100 is a radiopaque light-cured resin-based luting cement for porcelain (or composite) laminate veneer or inlay restoration.
GVC-100 is a radiopaque light-cured resin-based luting cement
The provided document is a 510(k) clearance letter from the FDA for a dental cement product named "GVC-100." It does not contain any information about acceptance criteria, device performance, study details (sample sizes, data provenance, expert qualifications, adjudication methods), or any information regarding AI, multi-reader multi-case studies, or standalone algorithm performance.
Therefore, I cannot provide the requested information based on the given input. The document is strictly a regulatory clearance notice and does not include scientific study results or performance data.
§ 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.