K243427
- 510(k) number
- K243427
- Device name
- QuickSleeper 5
- Applicant
- Dentalhitec FR
- Product code
- EGM — Injector, Jet, Mechanical-Powered
- Decision date
- 2025-08-01
- Date received
- 2024-11-05
- 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: K243427.pdf
Official FDA record: K243427
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.