FDA 510(k) K254142: Dia-X Sil Heavy Body
Summary & scoring by The Bell Brief (Dr. Jennifer Bell) using the Drill-Down Protocol (Drill-Down Score) — not the original publisher.
Why it matters for dental
Routine 510(k) clearance of another addition-cure silicone impression material (Dia-X Sil Heavy Body) expands the catalog of Class II impression materials available to U.S. dentists, but does not alter clinical workflow, billing, or regulatory burden.
Key points
- Product code ELW, Regulation 872.3660: Class II impression material cleared via substantial equivalence pathway.
- Manufacturer: DiaDent Group International; traditional 510(k) K254142.
- Material type listed as addition-cure silicone (heavy body) for dental impressions.
- No FDA recall, labeling change, or enforcement action attached to this clearance.
Who should care
Read the original on openFDA Dental Devices
Full reporting and any paywall content live on accessdata.fda.gov. We summarize and score; we do not republish.
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