TempFIT Temporary Crown and Bridge Resin

TempFIT Temporary Crown and Bridge Resin is a self-curing composite resin delivered in a two-component cartridge (base and catalyst pastes) for fabricating temporary dental restorations including crowns, bridges, inlays, onlays, and veneers. It is a prescription-use device intended for intraoral application.

Both the subject device and predicate (Luxatemp Ultra/Star, K101710) are two-paste, methacrylic resin-based systems with inorganic fillers, delivered in cartridges, with self-curing mechanisms. Physical properties are identical or substantially similar: working time ≥50s, setting time ≤10min, flexural strength ≥50MPa, water sorption ≤40μm/mm³, and solubility ≤7.5μm/mm³. The minor compositional difference does not affect intended use or performance.

ISO 10477 (resin-based filling materials), ISO 7405 (biocompatibility of materials), and ISO 10993 (biocompatibility evaluation of medical devices). Testing was performed according to these standards and the manufacturer's internal standard operating procedures (SOP).

The subject device is substantially equivalent because it shares the same indications for use, physical form, curing mechanism, delivery format, and clinical context as the predicate device. Both conform to identical physical property specifications under ISO 10477. The compositions contain only well-known industry chemicals with no novel materials; the minor compositional differences do not affect performance. The predicate device has been safely marketed without clinical adverse events, and biocompatibility testing confirms the subject device poses no new safety concerns.