“FLNT Base” and “FLNT Temp”

FLNT Base and FLNT Temp are polymethyl methacrylate (PMMA) materials used to fabricate removable or temporary dental structures such as crowns, bridges, and dentures using CAD/CAM milling technology. They are supplied in various shapes (blocks, discs, rods) and colors with single or multilayer aesthetic effects.

Both devices are PMMA-based polymers with cross-linking agents processed via polymerization. FLNT Base offers 10 shades and FLNT Temp offers 25 shades. The predicate device information regarding aesthetic effects was unavailable. Both are non-sterile, single-use materials supplied in various dimensions.

ISO 20795 (for FLNT Base), ISO 10477 (for FLNT Temp), ISO 10993 series for biocompatibility including cytotoxicity, irritation, sensitization, acute and chronic toxicity, pyrogenicity, implantation, genotoxicity, and carcinogenicity testing.

The devices are substantially equivalent because they have identical indications for use, similar PMMA composition with colorants, comparable manufacturing via polymerization, and meet all relevant performance standards (flexural strength, water sorption, water solubility, residue monomer) matching the predicate device. Minor differences in shade options and aesthetic effects do not raise safety or effectiveness concerns.