K231722
- 510(k) number
- K231722
- Device name
- SmarTooth
- Applicant
- Smartooth Co., Ltd. KR
- Product code
- NBL — Light-Induced Fluorescence Caries Detector
- Decision date
- 2024-05-01
- Date received
- 2023-06-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K231722.pdf
Official FDA record: K231722
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.