K261485
- 510(k) number
- K261485
- Device name
- Tetric plus Fill;Tetric plus Flow
- Applicant
- Ivoclar Vivadent, Inc. NY · US
- Product code
- EBF — Material, Tooth Shade, Resin
- Decision date
- 2026-07-01
- Date received
- 2026-05-05
- 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: K261485.pdf
Official FDA record: K261485
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.