510(k) · Cleared
ClearedEms Air-Flow Handy 2 Dental Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Electro Medical Systems SA · EFB Handpiece, Air-Powered, Dental
Cleared on Jul 25, 2002 as substantially equivalent to K991857 (Electro Medical Systems, Inc., 1999) after a 24-day review. Its family tree reaches back 2 generations to 1990. 22 later devices descend from it.
- Decided
- Jul 25, 2002
- Review
- 24 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K900709 (1990). 3 ancestors in all. 22 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK900709 Air Flow SiiElectro Medical Systems (Ems Sa) · 1990
- 1 generation backK991857 Airflow HandyElectro Medical Systems, Inc. · 1999
- This deviceK022119 Ems Air-Flow Handy 2 Dental HandpieceElectro Medical Systems SA · 2002
- Descendant · cites it directly · 18 of its ownK092289 Ems Air-Flow Handy PerioE.M.S Electro Medical Systems S.A · 2009
- Descendant · 2 generations on · 13 of its ownK110173 Ems Air-Flow Master PiezonE.M.S Electro Medical Systems S.A · 2011
- Descendant · 3 generations on · 4 of its ownK190124 EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneE.M.S Electro Medical Systems S.A · 2019 · Recalled
- Descendant · cites it directly · 3 of its ownK132478 Air-Flow Handy 3.0E.M.S Electro Medical Systems S.A · 2014
- Descendant · cites it directly · 3 of its ownK110379 Air-N-GOSatelec · 2011
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K092289Ems Air-Flow Handy PerioE.M.S Electro Medical Systems S.A · 2009 · cites it directly18descendants
- K110173Ems Air-Flow Master PiezonE.M.S Electro Medical Systems S.A · 2011 · 2 generations on13descendants
- K190124EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneE.M.S Electro Medical Systems S.A · 2019 · 3 generations on4descendants
- K132478Air-Flow Handy 3.0E.M.S Electro Medical Systems S.A · 2014 · cites it directly3descendants
- K110379Air-N-GOSatelec · 2011 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K900709 | Air Flow Sii | Electro Medical Systems (Ems Sa) | 1990 | — |
| −1 | K991857 | Airflow Handy | Electro Medical Systems, Inc. | 1999 | — |
| 0 (this device) | K022119 | Ems Air-Flow Handy 2 Dental Handpiece | Electro Medical Systems SA | 2002 | — |
| +1 | K092289 | Ems Air-Flow Handy Perio | E.M.S Electro Medical Systems S.A | 2009 | — |
| +2 | K110173 | Ems Air-Flow Master Piezon | E.M.S Electro Medical Systems S.A | 2011 | — |
| +3 | K190124 | EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One | E.M.S Electro Medical Systems S.A | 2019 | 3 |
| +1 | K132478 | Air-Flow Handy 3.0 | E.M.S Electro Medical Systems S.A | 2014 | — |
| +1 | K110379 | Air-N-GO | Satelec | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 EFB? 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 EFB device
- #1 K262144 DIAMED Handpiece;DIAMED Airmotor;DIAMED…score 13.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K991857 | Airflow HandySummary page 1…ets on orthodontic appliances. 4. DEVICE DESCRIPTION The AIR-FLOW@handy 2 is a modified version of the AirFlow@handy previously cleared under K991857. As with the original AirFlow* handy device, the proposed AIR-FLOW@handy 2 is a turbine-adaptable air polisher that consis… | 1999 |
What descends from it? (22)
See all 225 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K092289 (E.M.S Electro Medical Systems S.A, 2009) has gone furthest, with 18 descendants of its own.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EFB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EFB
209in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EFB
No recall names EFB since 2007.
Adverse event reports per year · EFB
83in 2025
MAUDE reports naming product code EFB, 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 | 12 | 61 | 0 | 13 |
| 2008 | 7 | 97 | 0 | 19 |
| 2009 | 11 | 120 | 0 | 40 |
| 2010 | 8 | 116 | 0 | 78 |
| 2011 | 4 | 168 | 0 | 96 |
| 2012 | 8 | 130 | 0 | 97 |
| 2013 | 3 | 207 | 0 | 61 |
| 2014 | 7 | 200 | 0 | 73 |
| 2015 | 7 | 296 | 0 | 87 |
| 2016 | 3 | 205 | 0 | 122 |
| 2017 | 7 | 246 | 0 | 153 |
| 2018 | 3 | 210 | 0 | 81 |
| 2019 | 3 | 348 | 0 | 117 |
| 2020 | 5 | 259 | 0 | 94 |
| 2021 | 2 | — | 0 | 123 |
| 2022 | 5 | 430 | 0 | 157 |
| 2023 | 4 | 158 | 0 | 116 |
| 2024 | 5 | 209 | 0 | 104 |
| 2025 | 1 | — | 0 | 83 |
| 2026 | 4 | 252 | 0 | — |
What is it indicated for?
The EMS AIR-FLOW@handy 2 Dental Handpiece is a dental handpiece intended for use in the cleaning and polishing of teeth by the projection of a mixture of water, air, and bicarbonate powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to prepare teeth for dental procedures such as the placement of composite fillings, porcelain inlays, and laminate veneers. The device can be used to clean implant abutments and to clean teeth prior to treatments such as shade matching, fluoridation, and bleaching. The device can also be used to degrease crowns and bridges prior to placement and clean fixed bands and brackets on orthodontic appliances.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022119: Ems Air-Flow Handy 2 Dental Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022119
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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