510(k) · Cleared
ClearedAir-Flow Master Standard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
(Ems Sa) Electro Medical Systems · EFB Handpiece, Air-Powered, Dental
Cleared on Dec 14, 2007 as substantially equivalent to K900709 (Electro Medical Systems (Ems Sa), 1990) after a 23-day review. Its family tree reaches back 1 generation to 1990. 25 later devices descend from it.
- Decided
- Dec 14, 2007
- Review
- 23 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K900709 (1990). 25 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK900709 Air Flow SiiElectro Medical Systems (Ems Sa) · 1990
- This deviceK073284 Air-Flow Master Standard(Ems Sa) Electro Medical Systems · 2007
- Descendant · cites it directly · 23 of its ownK082791 Ems Air-Flow MasterE.M.S Electro Medical Systems S.A · 2009
- Descendant · 2 generations on · 18 of its ownK092289 Ems Air-Flow Handy PerioE.M.S Electro Medical Systems S.A · 2009
- Descendant · cites it directly · 13 of its ownK110173 Ems Air-Flow Master PiezonE.M.S Electro Medical Systems S.A · 2011
- Descendant · 2 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 · 4 of its ownK132480 Air-Flow Handy 3.0 PerioE.M.S Electro Medical Systems S.A · 2014
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K082791Ems Air-Flow MasterE.M.S Electro Medical Systems S.A · 2009 · cites it directly23descendants
- 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 · cites it directly13descendants
- K190124EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneE.M.S Electro Medical Systems S.A · 2019 · 2 generations on4descendants
- K132480Air-Flow Handy 3.0 PerioE.M.S Electro Medical Systems S.A · 2014 · 2 generations on4descendants
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) | K073284 | Air-Flow Master Standard | (Ems Sa) Electro Medical Systems | 2007 | — |
| +1 | K082791 | Ems Air-Flow Master | E.M.S Electro Medical Systems S.A | 2009 | — |
| +2 | K092289 | Ems Air-Flow Handy Perio | E.M.S Electro Medical Systems S.A | 2009 | — |
| +1 | K110173 | Ems Air-Flow Master Piezon | E.M.S Electro Medical Systems S.A | 2011 | — |
| +2 | K190124 | EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One | E.M.S Electro Medical Systems S.A | 2019 | 3 |
| +2 | K132480 | Air-Flow Handy 3.0 Perio | E.M.S Electro Medical Systems S.A | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 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 |
|---|---|---|---|
| * | K900709 | Air Flow SiiSummary page 1…ece Classification Name: Airbrush and accessories/Dental handpiece and accessonies 3. PREDICATE DEVICES * EMS Electro Medical Systems SA, AIR-FLOW S2, K900709 4. DEVICE DESCRIPTION The AIR-FLOW MASTER STANDARD is an air-polishing unit containing an operating unit, air/water pres… | 1990 |
| † | K022119 | Ems Air-Flow Handy 2 Dental Handpiece | 2002 |
What descends from it? (25)
See all 254 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?
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 AIR-FLOW MASTER STANDARD is an air-polishing unit intended for use in the cleaning and polishing of teeth by the projection of water, air, and dental powders onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth. The device can also be used for the following cleaning procedures: * plaque removal for placement of sealants * surface preparation…
Read the full statement (134 words)
The AIR-FLOW MASTER STANDARD is an air-polishing unit intended for use in the cleaning and polishing of teeth by the projection of water, air, and dental powders onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth.
The device can also be used for the following cleaning procedures:
* plaque removal for placement of sealants
* surface preparation prior to bonding/cementation of inlays, onlays, crowns and veneers
* surface preparation prior to placing composite restorations
* effective plaque and stain removal for orthodontic patients
* cleaning prior to bonding ortho brackets
* cleaning implant fixture prior to loading
* stain removal for shade determination
* plaque removal prior to fluoride treatment
* plaque and stain removal prior to whitening procedure
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073284 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073284: Air-Flow Master Standard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073284
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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