K250009
- 510(k) number
- K250009
- Device name
- LED Curing Light (C01-X, C02-X)
- Applicant
- Premium Plus (Dongguan) Limited CN
- Product code
- EBZ — Activator, Ultraviolet, For Polymerization
- Decision date
- 2025-04-10
- Date received
- 2025-01-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K250009.pdf
Official FDA record: K250009
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.