(60 days)
Adhesive fixing of ceramic, composite or metal inlays, onlays, crowns, bridges, posts, screws, veneers and orthodontic strips
Unicem is classified as a Dental cement other than zinc oxide-eugenol (21 C.F.R. § 872.3275[b]) because it is a device composed of various materials other than zinc oxide-eugenol. Unicem is intended to affix dental devices such as crowns and bridges. Unicem self adhesive luting cement due to its newly developed chemistry combines the advantages of glass ionomer luting cements with esthetic properties of composite luting cements.
The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. Instead, it is a 510(k) premarket notification summary for a dental cement called Unicem, indicating its substantial equivalence to predicate devices. The document mainly covers:
- Submitter Information: Company details, contact person.
- Device Name: Proprietary, classification, and common names.
- Predicate Devices: A list of existing devices used for comparison.
- Description for Premarket Notification: Details about Unicem, its composition, and its intended use (affixing dental devices). It mentions toxicology testing for biocompatibility and comparison with predicate devices for effectiveness, focusing on physical and mechanical properties.
- FDA Correspondence: A letter from the FDA acknowledging the 510(k) submission and determining substantial equivalence.
- Indications for Use: The specified uses for the Unicem device.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving device performance based on the provided text. The document states that the device was compared to predicate devices for effectiveness based on physical and mechanical properties, and biocompatibility testing was carried out, but it does not detail specific acceptance criteria or the study methodology, sample sizes, ground truth, or expert involvement as requested.
§ 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.