510(k) · Cleared
ClearedW&H Handpiece Anesto, Model: RA-5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W&H Dentalwerk Buermoos GmbH · EGM Injector, Jet, Mechanical-Powered
Cleared on Jan 14, 2010 as substantially equivalent to K964802 (Intra Vantage, Inc., 1997) after a 388-day review. Its family tree reaches back 2 generations to 1991. 1 later device descends from it.
- Decided
- Jan 14, 2010
- Review
- 388 days
- Class
- Class II
- Product code
- EGM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K910446 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK910446 Stabident Local Anesthesia SystemFairfax Dental, Inc. · 1991
- 1 generation backK964802 Cyberjet Local Anesthesia SystemIntra Vantage, Inc. · 1997
- This deviceK083811 W&H Handpiece Anesto, Model: RA-5W&H Dentalwerk Buermoos GmbH · 2010
- Descendant · cites it directly · 0 of its ownK243427 QuickSleeper 5Dentalhitec · 2025
Most influential descendants
Showing 1 of 1 · See all- K243427QuickSleeper 5Dentalhitec · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910446 | Stabident Local Anesthesia System | Fairfax Dental, Inc. | 1991 | — |
| −1 | K964802 | Cyberjet Local Anesthesia System | Intra Vantage, Inc. | 1997 | — |
| 0 (this device) | K083811 | W&H Handpiece Anesto, Model: RA-5 | W&H Dentalwerk Buermoos GmbH | 2010 | — |
| +1 | K243427 | QuickSleeper 5 | Dentalhitec | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
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.
Top candidate predicates for a new EGM device
- #1 K243427 QuickSleeper 5score 10.4 · 3 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K964802 | Cyberjet Local Anesthesia SystemSummary page 1…Predicate Devices "IntraFlow HTP", Pro-Dex Micro Motors Inc., 510(k) exempt _Cyberjiet", Intra Vantage Inc., K964802 Device Description RA-5 "ANESTO' is a handpiece, which, on the one hand, is… | 1997 |
| * | — | IntraFlow HTP Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243427 | QuickSleeper 5 | 2025 | 0 |
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 19 years and passes through 3 companies; a new generation was cleared every 12.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K243427 (Dentalhitec, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EGM devicesEGM Injector, Jet, Mechanical-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Drilling system to perforate cortical bane in order to administer local anesthesia in spongiosa.
Application in dentistry.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083811 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083811: W&H Handpiece Anesto, Model: RA-5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083811
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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