510(k) · Cleared
ClearedCyberjet Local Anesthesia System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intra Vantage, Inc. · EGM Injector, Jet, Mechanical-Powered
Cleared on May 27, 1997 as substantially equivalent to K910446 (Fairfax Dental, Inc., 1991) after a 179-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it.
- Decided
- May 27, 1997
- Review
- 179 days
- Class
- Class II
- Product code
- EGM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910446 (1991). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK910446 Stabident Local Anesthesia SystemFairfax Dental, Inc. · 1991
- This deviceK964802 Cyberjet Local Anesthesia SystemIntra Vantage, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK083811 W&H Handpiece Anesto, Model: RA-5W&H Dentalwerk Buermoos GmbH · 2010
- Descendant · 2 generations on · 0 of its ownK243427 QuickSleeper 5Dentalhitec · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910446 | Stabident Local Anesthesia System | Fairfax Dental, Inc. | 1991 | — |
| 0 (this device) | K964802 | Cyberjet Local Anesthesia System | Intra Vantage, Inc. | 1997 | — |
| +1 | K083811 | W&H Handpiece Anesto, Model: RA-5 | W&H Dentalwerk Buermoos GmbH | 2010 | — |
| +2 | K243427 | QuickSleeper 5 | Dentalhitec | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K910446 | Stabident Local Anesthesia SystemSummary page 3…354 Bel Marin Keys, Suite | Novato, CA 94949 415.883.0484 415,883.3037 - fax 6. Equivalent/ Predicate Device(s): 1. Stabident System - Intraosseous Local Anesthesia - K910446 7. Description of the Device: Introduction. The Cyberjet™ is a dental device intended for intraosseous injection of local anest… | 1991 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083811 | W&H Handpiece Anesto, Model: RA-5 | 2010 | 1 |
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?
- Its one ancestor has no recall.
- Of its descendants, K083811 (W&H Dentalwerk Buermoos GmbH, 2010) has gone furthest, with 1 descendant 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.
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 intraosseous anesthesia for dental indications.
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/K964802 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964802: Cyberjet Local Anesthesia System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964802
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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