Any-Com Bulk

Any-Com Bulk is a light-cured, radiopaque, flowable composite resin material for dental restorations. It serves as a base or liner under direct restorations and can fill cavities up to 4mm in depth in a single increment. It is available in five shade options (A1, A2, A3, TL, Blue) for both anterior and posterior use.

The device contains Bis-GMA, UDMA, TEDMA, barium glass, and camphorquinone with approximately 66% inorganic filler by weight and particle sizes of 0.1–2.0 µm. It achieves a curing depth of 3.5 mm and flexural strength of 100 MPa. Water absorption is 30 µg/mm³ and solubility is 0.6 µg/mm³, with radiopacity over 2.9 mm.

ISO 4049 for performance testing (appearance, weight, curing depth, flexural strength, water sorption/solubility, color stability, and radiopacity). ISO 10993 series for biocompatibility testing including cytotoxicity, sensitization, irritation, acute/subacute toxicity, genotoxicity, implantation, chronic toxicity, and carcinogenicity.

The subject device shares the same indications for use, curing method (light-cured), delivery system (syringe), and technological performance profile as the predicate 3M Filtek Bulk Fill Flowable. Although minor raw material differences exist (TEDMA and barium glass versus BisEMA and procrylat resins), the performance metrics (similar flexural strength and curing depth) and comprehensive biocompatibility testing demonstrate equivalent safety and effectiveness, raising no concerns for clinical use.