K242591
- 510(k) number
- K242591
- Device name
- XERO-alpha
- Applicant
- DRTECH Corporation KR
- Product code
- EHD — Unit, X-Ray, Extraoral With Timer
- Decision date
- 2024-11-01
- Date received
- 2024-08-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K242591.pdf
Official FDA record: K242591
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.