(90 days)
The BASIS FLOW II is intended for fabrication or repair of the denture base.
BASIS FLOW II is supplied as components in powder and liguid form. The powder is primarily a polymer of polymethyl methacrylate (PMMA) with small quantities of initiator and color pigments. The liquid is primarily the monomer methyl methacrylate (MMA) with small quantities of a cross-linking agent and activator.
To fabricate the denture base, the powder and liguid materials are mixed and stirred to create a dough state that is packed or poured into a mold, saddle, or core. The resin then cures in a self-curing process (pressure vessel or via quick-setting).
This document is a 510(k) Premarket Notification from the FDA regarding a dental resin, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and expert involvement for an AI/ML device is not applicable and cannot be extracted from this document.
The document discusses the substantial equivalence of BALANCE FLOW II (subject device) to BALANCE FLOW (predicate device) based on physical and chemical properties and adherence to ISO standards for denture base polymers.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.