| K-number | K250823 |
| Device name | Any-Com Flow |
| Applicant | Mediclus Co., Ltd. |
| Product code | EBF |
| Device class | Class II |
| Decision date | Apr 14, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 872.3690 |
Any-Com Flow is a light-cured dental composite resin material used for anterior and posterior tooth restorations, as well as indirect restorations including inlays, onlays, and veneers. The material is supplied in a flowable syringe formulation with enhanced zirconia filler and is available in 9 tooth shades. After tooth preparation and shade selection, the material is applied and permanently bonded using a dentist's photopolymerizer.
Any-Com Flow differs from its predicate (Any-Com) primarily in viscosity—it is a single flowable type versus the predicate's single paste form. Both use methacrylate-based resin matrices with inorganic fillers and undergo light-induced polymerization. Performance specifications show minor variations: Any-Com Flow has curing depth of 2.2 mm versus predicate's 1.7–3 mm range, water absorption of 30 versus 29, solubility of 0.6 versus 0.7, and flexural strength of 125 MPa versus 101 MPa.
ISO 4049 (performance testing including curing depth, flexural strength, water absorption, solubility, color stability, and radiopacity) and ISO 10993-5, 10, and 11 (biocompatibility testing).
Any-Com Flow is substantially equivalent to Any-Com because both share the same indications for use (anterior/posterior restorations, indirect restorations), the same base chemistry (methacrylate resin with inorganic fillers), the same principle of light-induced polymerization, and the same regulatory classification and product code. Although viscosity differs, testing per ISO 4049 and ISO 10993 demonstrates that this difference does not raise safety or effectiveness concerns, and all performance metrics remain within acceptable ranges for the intended use.
View the full FDA submission: accessdata.fda.gov