(38 days)
Quadrant UniChem is a two component, self-curing curing dental composite filling material, including an etching agent (Quadrant Total Etch) and a two component, selfcuring enamel bonding agent, used in the adhesive restorative technique for the restoration of decayed teeth.
Cavity preparation is performed according to the principles of adhesive dentistry, adopting the minimal invasive technique for maximal preservation of sound tooth tissue.
Quadrant UniChem is a composite for universal use: the restoration of both anterior and posterior teeth. It can also be used for core build-up: the reconstruction of a tooth with insufficient material left as a result of decay, before crown preparation.
Quadrant UniChem is a two component, self-curing curing dental composite filling material, including an etching agent (Quadrant Total Etch) and a two component, selfcuring enamel bonding agent.
This document is a 510(k) clearance letter from the FDA for a dental composite filling material called "Quadrant UniChem." It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
Therefore, I cannot provide the requested information based on the provided text. The document primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.