K223414
- 510(k) number
- K223414
- Device name
- Curing Light, Model: MaxCure 9
- Applicant
- Guilin Refine Medical Instrument Co., Ltd. CN
- Product code
- EBZ — Activator, Ultraviolet, For Polymerization
- Decision date
- 2023-11-15
- Date received
- 2022-11-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K223414.pdf
Official FDA record: K223414
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.