K242360
- 510(k) number
- K242360
- Device name
- Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator
- Applicant
- Dent4you AG CH
- Product code
- ELW — Material, Impression
- Decision date
- 2024-11-15
- Date received
- 2024-08-09
- 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: K242360.pdf
Official FDA record: K242360
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.