K240694
- 510(k) number
- K240694
- Device name
- FORMA Composite (Shade A3D)
- Applicant
- Ultradent Products, Inc. UT · US
- Product code
- EBF — Material, Tooth Shade, Resin
- Decision date
- 2024-03-15
- Date received
- 2024-03-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K240694.pdf
Official FDA record: K240694
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.