K260783
- 510(k) number
- K260783
- Device name
- Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One
- Applicant
- Kulzer, LLC IN · US
- Product code
- EBF — Material, Tooth Shade, Resin
- Decision date
- 2026-03-11
- Date received
- 2026-03-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K260783.pdf
Official FDA record: K260783
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.