K231181
- 510(k) number
- K231181
- Device name
- bright CT
- Applicant
- Dentium Co., Ltd (Ict Branch) KR
- Product code
- OAS — X-Ray, Tomography, Computed, Dental
- Decision date
- 2023-12-14
- Date received
- 2023-04-26
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K231181.pdf
Official FDA record: K231181
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.