(49 days)
MaxCem is intended for indirect cementation of porcelain, resin and metal-based inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer indications.
The device is a self-etch adhesive resin cement offered in a paste/paste formulation indicated for the cementation of indirect ceramic, resin and metal restorations. Due to its self-etching and adhering properties, MaxCem does not require the use of an etchant, primer or adhesive. This product contains 68% filler by weight with an average filler particle size of 4 microns in the base formulation, is radiopaque and releases fluoride. The dual-cure material is packaged in automix dual barrel syringes which allow the user to deliver the desired volume of cement directly into the restoration or tooth cavity.
This document is a 510(k) premarket notification for a dental cement called MaxCem. It describes the device, its intended use, and claims substantial equivalence to an existing device (UniCem). This is primarily a regulatory filing and does not contain acceptance criteria or a study proving that the device meets acceptance criteria.
Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory approval based on substantial equivalence, rather than a performance study with defined acceptance criteria.
§ 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.