K232810
- 510(k) number
- K232810
- Device name
- Dental Handpiece, Wireless Endodontic Handpiece, endoit
- Applicant
- Micro-Nx Co., Ltd. KR
- Product code
- EKX — Handpiece, Direct Drive, Ac-Powered
- Decision date
- 2023-11-09
- Date received
- 2023-09-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K232810.pdf
Official FDA record: K232810
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.