510(k) · Cleared
ClearedAIR-FLOW PLUS Prophylaxis powder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
E.M.S Electro Medical Systems S.A · EJR Agent, Polishing, Abrasive, Oral Cavity
Cleared on Sep 11, 2017 as substantially equivalent to K082791 (E.M.S Electro Medical Systems S.A, 2009) and 1 other predicate after a 140-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Sep 11, 2017
- Review
- 140 days
- Class
- Class I
- Product code
- EJR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K900709 (1990). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK900709 Air Flow SiiElectro Medical Systems (Ems Sa) · 1990
- 4 generations backK991857 Airflow HandyElectro Medical Systems, Inc. · 1999
- 3 generations backK022119 Ems Air-Flow Handy 2 Dental HandpieceElectro Medical Systems SA · 2002
- 2 generations backK092289 Ems Air-Flow Handy PerioE.M.S Electro Medical Systems S.A · 2009
- 1 generation backK110173 Ems Air-Flow Master PiezonE.M.S Electro Medical Systems S.A · 2011
- This deviceK171189 AIR-FLOW PLUS Prophylaxis powderE.M.S Electro Medical Systems S.A · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K900709 | Air Flow Sii | Electro Medical Systems (Ems Sa) | 1990 | — |
| −4 | K991857 | Airflow Handy | Electro Medical Systems, Inc. | 1999 | — |
| −3 | 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 | — |
| −1 | K110173 | Ems Air-Flow Master Piezon | E.M.S Electro Medical Systems S.A | 2011 | — |
| 0 (this device) | K171189 | AIR-FLOW PLUS Prophylaxis powder | E.M.S Electro Medical Systems S.A | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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 EJR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K082791 | Ems Air-Flow MasterSummary page 4…is Powder is a substantially equivalent new version of the legally marketed 510(k) exempt powders E.M.S PERIO Powder (predicate, exempt but included in K082791 cleared on 02/18/2009) and E.M.S. Soft Powder(reference device exempt but included in K110173 cleared on 04/07/2011). Th… | 2009 |
| * | K110173 | Ems Air-Flow Master PiezonSummary page 4…ers E.M.S PERIO Powder (predicate, exempt but included in K082791 cleared on 02/18/2009) and E.M.S. Soft Powder(reference device exempt but included in K110173 cleared on 04/07/2011). The proposed device is submitted via premarket notification [510(k) pathway] because the additio… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 4 companies; a new generation was cleared every 6.4 years on median.
- None of the 15 ancestors has a recall.
- 5 other devices also cite its predicate K082791.
How does its category compare?
All EJR devicesEJR Agent, Polishing, Abrasive, Oral Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · EJR
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · EJR
Too few EJR 510(k)s in any year since 2007 to give a median.
Recalls per year · EJR
No recall names EJR since 2007.
Adverse event reports per year · EJR
4in 2025
MAUDE reports naming product code EJR, 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 | 1 | — | 0 | 6 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 2 | — | 0 | 3 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 8 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AIR-FLOW PLUS Prophylaxis Powder is indicated for use with EMS dental handpieces for cleaning and preparation of teeth.
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/K171189 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171189: AIR-FLOW PLUS Prophylaxis powder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171189
Report an extraction error
Are you the manufacturer?
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