510(k) · Cleared
ClearedQuickSleeper 5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentalhitec · EGM Injector, Jet, Mechanical-Powered
Cleared on Aug 1, 2025 as substantially equivalent to K083811 (W&H Dentalwerk Buermoos GmbH, 2010) after a 269-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Aug 1, 2025
- Review
- 269 days
- Class
- Class II
- Product code
- EGM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K910446 (1991). No later device cites it as a predicate yet.
- Root · 3 generations backK910446 Stabident Local Anesthesia SystemFairfax Dental, Inc. · 1991
- 2 generations backK964802 Cyberjet Local Anesthesia SystemIntra Vantage, Inc. · 1997
- 1 generation backK083811 W&H Handpiece Anesto, Model: RA-5W&H Dentalwerk Buermoos GmbH · 2010
- This deviceK243427 QuickSleeper 5Dentalhitec · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K910446 | Stabident Local Anesthesia System | Fairfax Dental, Inc. | 1991 | — |
| −2 | K964802 | Cyberjet Local Anesthesia System | Intra Vantage, Inc. | 1997 | — |
| −1 | K083811 | W&H Handpiece Anesto, Model: RA-5 | W&H Dentalwerk Buermoos GmbH | 2010 | — |
| 0 (this device) | K243427 | QuickSleeper 5 | Dentalhitec | 2025 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EGM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K083811 | W&H Handpiece Anesto, Model: RA-5Summary page 5…872.4475, Spring-powered jet injector Device Class: Class II Device Product Code: EGM, EJI Predicate Device: K083811 – RA-5 ANESTO Handpiece Reference Device: K061904 – The WAND STA System Device Description The Dentalhitec… | 2010 |
| † | K061904 | Compudent Sta | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 4 companies; a new generation was cleared every 12.6 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All EGM devicesEGM Injector, Jet, Mechanical-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · EGM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EGM
Too few EGM 510(k)s in any year since 2007 to give a median.
Recalls per year · EGM
No recall names EGM since 2007.
Adverse event reports per year · EGM
1in 2017
MAUDE reports naming product code EGM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Administration of local anesthesia for dental procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K243427 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243427: QuickSleeper 5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243427
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026