K243921
- 510(k) number
- K243921
- Device name
- LED Curing Lights (DB686 HALO)
- Applicant
- Foshan Coxo Medical Instrument Co., Ltd. CN
- Product code
- EBZ — Activator, Ultraviolet, For Polymerization
- Decision date
- 2025-04-11
- Date received
- 2024-12-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K243921.pdf
Official FDA record: K243921
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.