510(k) · Cleared
ClearedAirflow Handy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Electro Medical Systems, Inc. · EFB Handpiece, Air-Powered, Dental
Cleared on Oct 7, 1999 as substantially equivalent to K900709 (Electro Medical Systems (Ems Sa), 1990) and 1 other predicate after a 128-day review. Its family tree reaches back 1 generation to 1990. 23 later devices descend from it.
- Decided
- Oct 7, 1999
- Review
- 128 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K900709 (1990). 2 ancestors in all. 23 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK900709 Air Flow SiiElectro Medical Systems (Ems Sa) · 1990
- This deviceK991857 Airflow HandyElectro Medical Systems, Inc. · 1999
- Descendant · cites it directly · 22 of its ownK022119 Ems Air-Flow Handy 2 Dental HandpieceElectro Medical Systems SA · 2002
- Descendant · 2 generations on · 18 of its ownK092289 Ems Air-Flow Handy PerioE.M.S Electro Medical Systems S.A · 2009
- Descendant · 3 generations on · 13 of its ownK110173 Ems Air-Flow Master PiezonE.M.S Electro Medical Systems S.A · 2011
- Descendant · 4 generations on · 4 of its ownK190124 EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneE.M.S Electro Medical Systems S.A · 2019 · Recalled
- Descendant · 2 generations on · 3 of its ownK132478 Air-Flow Handy 3.0E.M.S Electro Medical Systems S.A · 2014
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K022119Ems Air-Flow Handy 2 Dental HandpieceElectro Medical Systems SA · 2002 · cites it directly22descendants
- K092289Ems Air-Flow Handy PerioE.M.S Electro Medical Systems S.A · 2009 · 2 generations on18descendants
- K110173Ems Air-Flow Master PiezonE.M.S Electro Medical Systems S.A · 2011 · 3 generations on13descendants
- K190124EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneE.M.S Electro Medical Systems S.A · 2019 · 4 generations on4descendants
- K132478Air-Flow Handy 3.0E.M.S Electro Medical Systems S.A · 2014 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900709 | Air Flow Sii | Electro Medical Systems (Ems Sa) | 1990 | — |
| 0 (this device) | K991857 | Airflow Handy | Electro Medical Systems, Inc. | 1999 | — |
| +1 | K022119 | Ems Air-Flow Handy 2 Dental Handpiece | Electro Medical Systems SA | 2002 | — |
| +2 | K092289 | Ems Air-Flow Handy Perio | E.M.S Electro Medical Systems S.A | 2009 | — |
| +3 | K110173 | Ems Air-Flow Master Piezon | E.M.S Electro Medical Systems S.A | 2011 | — |
| +4 | K190124 | EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One | E.M.S Electro Medical Systems S.A | 2019 | 3 |
| +2 | K132478 | Air-Flow Handy 3.0 | E.M.S Electro Medical Systems S.A | 2014 | — |
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 |
|---|---|---|
| 2002 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K900709 | Air Flow SiiSummary page 2…CE NAME Proprietary Name: AirFlow handy Common/Usual Name: Dental handpiece Classification Name: Dental handpiece and accessories 3. PREDICATE DEVICES ¢ AirFlow SII (K900709) e Prophyflex 2, Model 2012 (K973876) 4. DEVICE DESCRIPTION The AirFlow handy is a hand-held device containing air and water li… | 1990 |
| * | K973876 | Prophyflex 2, Model 2012Summary page 2…ndy Common/Usual Name: Dental handpiece Classification Name: Dental handpiece and accessories 3. PREDICATE DEVICES ¢ AirFlow SII (K900709) e Prophyflex 2, Model 2012 (K973876) 4. DEVICE DESCRIPTION The AirFlow handy is a hand-held device containing air and water lines, powder chamber with cap, and Air… | 1997 |
What descends from it? (23)
See all 231 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022119 | Ems Air-Flow Handy 2 Dental Handpiece | 2002 | 22 |
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?
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 AirFlow handy is a dental handpiece intended for use in the cleaning and polishing of teeth by the projection of water, air, and bicarbonate powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to clean teeth prior to dental procedures which require a clean tooth surface such as the placement of composite fillings, inlays, and laminate veneers.
The device can also be used to clean the following:
• implant abutments and teeth prior to treatments such as shade matching, fluoridation, and bleaching
• crowns and bridges
• fixed bands and brackets prior to placement on orthodontic appliances.
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/K991857 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991857: Airflow Handy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991857
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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