510(k) clearance
Dia-X Sil Heavy Body
- 510(k) number
- K254142
- Applicant
- DiaDent Group International
- Decision date
- Sep 16, 2026
- Date received
- Dec 22, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- ELW
- Device type
- Material, Impression
- Device class
- Class II
- Regulation
- 21 CFR 872.3660
- Advisory committee
- Dental
- Statement or summary
- Summary
- Third party
- N
- Location
- Cheongju-Si, KR