Class Class II
QuickSleeper 5 (K243427)
Description
QuickSleeper 5 by Dentalhitec, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243427
Clearance Date2025-08-01
Clearance TypeTraditional
Product CodeEGM
Regulation Number872.4475
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243427
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. QuickSleeper 5 (K243427) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K083811 | W&H HANDPIECE ANESTO, MODEL: RA-5 | W&H Dentalwerk Buermoos GmbH | 2010 |
| K061904 | COMPUDENT STA | Milestone Scientific, Inc. | 2006 |
Trace the full predicate network for K243427
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.