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The Tracker / September 2026 / K254152

510(k) cleared

Dia-X Sil Light Body

DiaDent Group International · Sep 16, 2026 · K254152

FDA cleared the Dia-X Sil Light Body from DiaDent Group International on Sep 16, 2026 under K254152, a traditional 510(k). The device falls under product code ELW, Material, Impression, regulated at 21 CFR 872.3660 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Dec 22, 2025. The decision came 268 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

DiaDent Group International has 5 other decisions in the tracker over the last 12 months: K254142 (Dia-X Sil Heavy Body), K261166 (DIA-CEM), K261093 (DIAFIL), K261071 (DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)).

Questions & Answers

What did FDA clear under K254152?

K254152 is the FDA 510(k) for Dia-X Sil Light Body, submitted by DiaDent Group International. FDA's decision date was Sep 16, 2026, under product code ELW (Material, Impression).

Who makes the Dia-X Sil Light Body?

DiaDent Group International, based in Cheongju-Si, is the applicant of record for K254152.

How long did the K254152 review take?

FDA received the submission on Dec 22, 2025 and issued its decision on Sep 16, 2026, 268 days later.

← All decisions in September 2026

Sources