K232551
- 510(k) number
- K232551
- Device name
- EM-07 Cordless Endo Motor
- Applicant
- Forum Engineering Technologies (96) , Ltd. IL
- Product code
- EKX — Handpiece, Direct Drive, Ac-Powered
- Decision date
- 2024-07-09
- Date received
- 2023-08-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K232551
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.