K262228
- 510(k) number
- K262228
- Device name
- Transcend Bulk Fill Flowable Composite
- Applicant
- Ultradent Products, Inc. UT · US
- Product code
- EBF — Material, Tooth Shade, Resin
- Decision date
- 2026-07-01
- Date received
- 2026-06-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K262228.pdf
Official FDA record: K262228
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.