K231864
- 510(k) number
- K231864
- Device name
- Fiber Optic Brushless Electronic Micromotor, model: iM100
- Applicant
- Codent Technical Industry Co., Ltd. TW
- Product code
- EBW — Controller, Foot, Handpiece And Cord
- Decision date
- 2024-03-11
- Date received
- 2023-06-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K231864.pdf
Official FDA record: K231864
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.