Submission Details
| 510(k) Number | K243427 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
QuickSleeper 5
Aug 2025
Decision
269d
Days
Class 2
Risk
About This 510(k) Submission
K243427 is an FDA 510(k) clearance for the QuickSleeper 5, 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 review panel. Regulated under 21 CFR 872.4475.
Device Classification
| Product Code | EGM — Injector, Jet, Mechanical-powered |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.4475 |
Manufacturer
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