Dia-X Sil Bite— 510(k) K254112
Substantially EquivalentDiaDent Group International
FDA 510(k) clearance K254112 for Dia-X Sil Bite, Substantially Equivalent on 2026-03-19. Applicant: DiaDent Group International. Device class: 2.
Summary
DiaDent Group International's Dia-X Sil Bite is filed under ELW, impression materials. The record doesn't describe the material beyond its name and that code name.
Class II, 21 CFR 872.3660. It was a Traditional 510(k), and Dental is both the classification panel and the review panel.
DiaDent Group International filed from Cheongju-Si, South Korea. The decision came 90 calendar days after FDA received it (December 19, 2025 to March 19, 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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