BACKGROUNDRegulatoryTier 1
FDA 510(k) K254152: Dia-X Sil Light 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 a new addition-cure silicone impression material does not change clinical practice or billing rules for U.S. dental offices.
Key points
- Manufacturer: DiaDent Group International; product name: Dia-X Sil Light Body.
- Device classified as Class II impression material under 21 CFR 872.3660 (product code ELW).
- Clearance granted via traditional substantial-equivalence pathway (K254152); no novel technology or new clinical indications.
- Dentists and DSO procurement teams can add the material to their formulary without regulatory or payer-policy implications.
Who should care
OwnerStaff
Read the original on openFDA Dental Devices
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