K242103
- 510(k) number
- K242103
- Device name
- TRIOS Ready Tip
- Applicant
- 3Shape TRIOS A/S DK
- Product code
- NBL — Light-Induced Fluorescence Caries Detector
- Decision date
- 2025-04-04
- Date received
- 2024-07-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K242103.pdf
Official FDA record: K242103
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.