K243911
- 510(k) number
- K243911
- Device name
- HPR Cordless Hygiene Handpiece
- Applicant
- Handpiece Headquarters CA · US
- Product code
- EKX — Handpiece, Direct Drive, Ac-Powered
- Decision date
- 2024-12-20
- Date received
- 2024-12-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Dental
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K243911
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.