K261071
- 510(k) number
- K261071
- Device name
- DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)
- Applicant
- DiaDent Group International KR
- Product code
- EBF — Material, Tooth Shade, Resin
- Decision date
- 2026-05-19
- Date received
- 2026-04-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K261071.pdf
Official FDA record: K261071
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.