K243427 is an FDA 510(k) clearance for the QuickSleeper 5. This device is classified as a Injector, Jet, Mechanical-powered (Class II - Special Controls, product code EGM).
Submitted by Dentalhitec (Mazieres En Mauges, FR). The FDA issued a Cleared decision on August 1, 2025, 269 days after receiving the submission on November 5, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4475.
| 510(k) Number | K243427 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 2024 |
| Decision Date | August 01, 2025 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EGM - Injector, Jet, Mechanical-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4475 |