K240660
- 510(k) number
- K240660
- Device name
- Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active
- Applicant
- Kulzer, LLC IN · US
- Product code
- EBF — Material, Tooth Shade, Resin
- Decision date
- 2024-09-17
- Date received
- 2024-03-08
- 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: K240660.pdf
Official FDA record: K240660
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.