K254112
- 510(k) number
- K254112
- Device name
- Dia-X Sil Bite
- Applicant
- DiaDent Group International KR
- Product code
- ELW — Material, Impression
- Decision date
- 2026-03-19
- Date received
- 2025-12-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K254112.pdf
Official FDA record: K254112
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.