K261404
- 510(k) number
- K261404
- Device name
- UltraEZ
- Applicant
- Ultradent Products, Inc. UT · US
- Product code
- LBH — Varnish, Cavity
- Decision date
- 2026-04-30
- Date received
- 2026-04-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Flag
- Third-party review
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K261404.pdf
Official FDA record: K261404
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.