Dia-X Sil Light Body— 510(k) K254152
Substantially EquivalentDiaDent Group International
FDA 510(k) clearance K254152 for Dia-X Sil Light Body, Substantially Equivalent on 2026-09-16. Applicant: DiaDent Group International. Device class: 2.
Summary
DiaDent Group International submitted Dia-X Sil Light Body under product code ELW (Material, Impression). Beyond the name and code, the record says nothing about the material.
Class II, 21 CFR 872.3660. Dental is both the classification panel and the review panel. It was a Traditional 510(k), decided Substantially Equivalent.
The company filed from Cheongju-Si, South Korea. FDA received it on December 22, 2025, and the decision came on September 16, 2026, 268 calendar days later.
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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