Partial Flex

Partial Flex is a polypropylene-based dental resin supplied as granular pellets in aluminum tubes (27g) or plastic bags (250g) in light pink or natural color. It is used to fabricate partial or full removable dentures and occlusal splints or night guards through injection molding.

Partial Flex is made from polypropylene resin in pellet form, whereas the predicate device (TCS UNBREAKABLE) uses polyamide in granular form. Both are denture base materials with similar indications for use. Partial Flex exhibits hypoallergenic properties, no discoloration risk, and unbreakable characteristics, and meets physical testing standards for dental base polymers including color stability, translucency, flexural strength, and sorption.

ISO 20795 (bench testing for dental base polymers), ISO 10993 (biocompatibility testing including intracutaneous injection test, Kligman maximization test, and L929 MEM elution test).

Partial Flex is substantially equivalent because it shares the same indications for use (fabrication of removable dentures, orthodontic devices, and occlusal splints), is used in the same manner (injection molding), and meets all applicable performance standards for dental base polymers despite using polypropylene instead of the predicate's polyamide. The nonclinical testing demonstrates biocompatibility and physical properties sufficient for the intended use, establishing functional and performance equivalence to the predicate device.