K252464
- 510(k) number
- K252464
- Device name
- Surgical Microscope (OMS2360, OMS2380)
- Applicant
- Zumax Medical Co., Ltd. CN
- Product code
- NBL — Light-Induced Fluorescence Caries Detector
- Decision date
- 2026-04-28
- Date received
- 2025-08-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K252464.pdf
Official FDA record: K252464
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.