K231845
- 510(k) number
- K231845
- Device name
- Dental unit Model: Mare
- Applicant
- Foshan Safety Medical Equipment Co., Ltd. CN
- Product code
- EIA — Unit, Operative Dental
- Decision date
- 2024-02-28
- Date received
- 2023-06-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K231845.pdf
Official FDA record: K231845
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.