K233308
- 510(k) number
- K233308
- Device name
- Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)
- Applicant
- Nakanishi, Inc. JP
- Product code
- EFB — Handpiece, Air-Powered, Dental
- Decision date
- 2024-04-25
- Date received
- 2023-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K233308.pdf
Official FDA record: K233308
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.