K250735
- 510(k) number
- K250735
- Device name
- Dental Barrier and Sleeves
- Applicant
- Fomed Industries, Inc. CN
- Product code
- PEM — Dental Barriers And Sleeves
- Decision date
- 2025-06-10
- Date received
- 2025-03-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250735.pdf
Official FDA record: K250735
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.