K-numberK250823
Device nameAny-Com Flow
ApplicantMediclus Co., Ltd.
Product codeEBF
Device classClass II
Decision dateApr 14, 2025
DecisionSubstantially Equivalent
Regulation872.3690
AI Summary extracted from FDA summary PDF · never regenerated
Intended use

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.

Technological characteristics

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.

Test standards cited

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).

Substantial equivalence argument

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.

Extracted by AI from the official FDA summary PDF →
Source

View the full FDA submission: accessdata.fda.gov

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