K253461
- 510(k) number
- K253461
- Device name
- Demi Pro
- Applicant
- Meta Systems Co., Ltd. KR
- Product code
- EBZ — Activator, Ultraviolet, For Polymerization
- Decision date
- 2025-10-14
- Date received
- 2025-10-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K253461.pdf
Official FDA record: K253461
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.