Dia-X Sil Heavy Body— 510(k) K254142
Substantially EquivalentDiaDent Group International
FDA 510(k) clearance K254142 for Dia-X Sil Heavy Body, Substantially Equivalent on 2026-09-16. Applicant: DiaDent Group International. Device class: 2.
Summary
Dia-X Sil Heavy Body is from DiaDent Group International, filed under product code ELW (Material, Impression). The record doesn't describe the material beyond its name and code.
Class II, 21 CFR 872.3660. Dental is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.
DiaDent filed from Cheongju-Si, South Korea. The decision came 268 calendar days after FDA received it (December 22, 2025 to September 16, 2026).
Clearance details
- Applicant
- DiaDent Group International
- Product code
- Product code ELW
- Device class
- Class 2
- Regulation
- 21 CFR 872.3660
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cheongju-Si, KR
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