K242097
- 510(k) number
- K242097
- Device name
- DenMat Bulk Fill Composite
- Applicant
- Den-Mat Holdings, LLC CA · US
- Product code
- EBF — Material, Tooth Shade, Resin
- Decision date
- 2024-10-15
- Date received
- 2024-07-18
- 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: K242097.pdf
Official FDA record: K242097
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.