K233395
- 510(k) number
- K233395
- Device name
- Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)
- Applicant
- Alliage S/A Industrias Médico Odontológica BR
- Product code
- EHD — Unit, X-Ray, Extraoral With Timer
- Decision date
- 2024-01-03
- Date received
- 2023-10-03
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K233395.pdf
Official FDA record: K233395
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.