K-numberK250267
Device nameVisalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068)
ApplicantKettenbach GmbH & Co. KG
Product codeEBF
Device classClass II
Decision dateMar 14, 2025
DecisionSubstantially Equivalent
Regulation872.3690
AI Summary extracted from FDA summary PDF · never regenerated
Intended use

Visalys® Bulk Fill and Visalys® Bulk Flow are light-cured, nano-hybrid dental composite resins used to restore tooth structure lost to caries, fractures, wear, or developmental disorders. Bulk Fill is a modelable composite available in 4g syringes and 0.25g caps; Bulk Flow is a flowable composite in 2g syringes and 0.25g caps. Both are applied in layers up to 4mm thick and are radio-opaque with universal shade.

Technological characteristics

Both devices are light-cured, methacrylate-based nano-hybrid composites with inorganic fillers including ytterbium fluoride. Visalys® Bulk Fill contains approximately 61 vol% fillers (82% by weight) with 2.5mm aluminum radiopacity; Visalys® Bulk Flow contains approximately 47 vol% fillers (72% by weight) with 2.0mm aluminum radiopacity. Both have filler particle sizes of 0.01–5 µm, aliphatic dimethacrylate polymer bases, and meet DIN EN ISO 4049 color stability requirements.

Test standards cited

Biocompatibility testing per ISO 10993 series (cytotoxicity, sensitization, genotoxicity, toxicological risk assessment, chemical characterization, and biocompatibility evaluation); mechanical properties per ISO 4049 (light sensitivity, depth of cure, flexural strength, elastic modulus, water sorption, solubility, shade, color stability, radio-opacity, volume shrinkage); bond strength per ISO 29022; radio-opacity per ISO 13116; volume shrinkage per ISO 17304; and color per ISO 7491/ANSI ADA Spec. 80.

Substantial equivalence argument

Visalys® Bulk Fill and Bulk Flow are substantially equivalent to Venus Bulk Flow ONE because they share the same technology platform (light-cured nano-hybrid methacrylate composites with similar formulation, filler types, and particle sizes), cover all the same clinical indications plus additional uses, and demonstrate equivalent or superior mechanical and biocompatibility performance across all tested parameters. The differences in viscosity (modelable vs. flowable) and filler loading do not affect the fundamental intended purpose, and biocompatibility data for Bulk Flow encompasses Bulk Fill since more relevant toxicological ingredients are present in higher concentrations in the flow version.

Extracted by AI from the official FDA summary PDF →
Source

View the full FDA submission: accessdata.fda.gov

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