510(k) · Cleared
Recalled · Class II · 2024EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One
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 · ELC Scaler, Ultrasonic
Cleared on Oct 20, 2019 as substantially equivalent to K110173 (E.M.S Electro Medical Systems S.A, 2011) after a 268-day review. Its family tree reaches back 5 generations to 1990. 4 later devices descend from it. It has been recalled 3 times.
- Decided
- Oct 20, 2019
- Review
- 268 days
- Class
- Class II
- Product code
- ELC
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 5 generations to K900709 (1990). 15 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- 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 deviceK190124 EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneE.M.S Electro Medical Systems S.A · 2019
- Descendant · cites it directly · 1 of its ownK231391 Combi TouchMectron S.P.A. · 2023
- Descendant · cites it directly · 0 of its ownK260773 Varios Combi Pro2Nakanishi, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK253254 GBT Machine Airflow Prophylaxis MasterE.M.S Electro Medical Systems S.A · 2026
- Descendant · 2 generations on · 0 of its ownK251425 turbodent touchMectron S.P.A. · 2025
Most influential descendants
Showing 4 of 4 · See all- K231391Combi TouchMectron S.P.A. · 2023 · cites it directly1descendant
- K260773Varios Combi Pro2Nakanishi, Inc. · 2026 · cites it directly0descendants
- K253254GBT Machine Airflow Prophylaxis MasterE.M.S Electro Medical Systems S.A · 2026 · cites it directly0descendants
- K251425turbodent touchMectron S.P.A. · 2025 · 2 generations on0descendants
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) | K190124 | EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One | E.M.S Electro Medical Systems S.A | 2019 | — |
| +1 | K231391 | Combi Touch | Mectron S.P.A. | 2023 | — |
| +1 | K260773 | Varios Combi Pro2 | Nakanishi, Inc. | 2026 | — |
| +1 | K253254 | GBT Machine Airflow Prophylaxis Master | E.M.S Electro Medical Systems S.A | 2026 | — |
| +2 | K251425 | turbodent touch | Mectron S.P.A. | 2025 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 ELC? 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 ELC device
- #1 K260773 Varios Combi Pro2score 12.5 · 6 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 |
|---|---|---|---|
| * | K110173 | Ems Air-Flow Master PiezonSummary page 7…3. Predicate Devices The proposed EMS AIRFLOW Prophylaxis Master and AIRFLOW One are substantially equivalent to the legally marketed AIR-FLOW MASTER PIEZON (K110173, cleared on 04/07/2011). This predicate has not been subject to a design-related recall. No reference devices were used in thi… | 2011 |
| † | K140990 | Ems Piezon 707 Bik and Piezon 707 Bik Led | 2015 |
| † | K171174 | PERIO-FLOW nozzle | 2017 |
What descends from it? (4)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 13, 2024 | Class II | Z-1686-2024 | Process control | Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles). |
| Mar 13, 2024 | Class II | Z-1687-2024 | Process control | Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles). |
| Mar 13, 2024 | Class II | Z-1688-2024 | Process control | Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 7.2 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K231391 (Mectron S.P.A., 2023) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K110173.
How does its category compare?
All ELC devicesELC Scaler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · ELC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ELC
104in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ELC
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ELC
284in 2025
MAUDE reports naming product code ELC, 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 | 6 | 92 | 0 | 12 |
| 2008 | 4 | 216 | 0 | 58 |
| 2009 | 4 | 121 | 0 | 108 |
| 2010 | 4 | 201 | 0 | 79 |
| 2011 | 3 | 122 | 0 | 5 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 13 | 174 | 0 | 6 |
| 2014 | 6 | 193 | 0 | 37 |
| 2015 | 5 | 150 | 0 | 135 |
| 2016 | 3 | 88 | 0 | 169 |
| 2017 | 2 | — | 0 | 356 |
| 2018 | 1 | — | 0 | 289 |
| 2019 | 4 | 192 | 0 | 302 |
| 2020 | 1 | — | 0 | 164 |
| 2021 | 3 | 196 | 0 | 166 |
| 2022 | 2 | — | 2 | 165 |
| 2023 | 5 | 258 | 0 | 210 |
| 2024 | 4 | 104 | 0 | 219 |
| 2025 | 2 | — | 0 | 284 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The AIRFLOW Prophylaxis Master combines the functions of an ultrasonic scaler and air-polishing unit within a single chassis. The AIRFLOW Prophylaxis Master is intended for use in the following dental and periodontal applications: • Removing supra and subgingival calculus deposits and stains from teeth • Periodontal pocket lavage with simultaneous ultrasonic tip movement • Scaling and root planing • Releasing crowns, bridges, inlays, and posts as well as…
Read the full statement (442 words)
The AIRFLOW Prophylaxis Master combines the functions of an ultrasonic scaler and air-polishing unit within a single chassis. The AIRFLOW Prophylaxis Master is intended for use in the following dental and periodontal applications:
• Removing supra and subgingival calculus deposits and stains from teeth
• Periodontal pocket lavage with simultaneous ultrasonic tip movement
• Scaling and root planing
• Releasing crowns, bridges, inlays, and posts as well as condensing gutta percha
• Plugging for amalgam condensation
• Amalgam burnishing
• Preparing, cleaning and irrigating root canals
• Cavity preparation
• Cementing inlays and onlays
• Retrograde preparation of root canals
The AIRFLOW Prophylaxis Master is 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 AIRFLOW Prophylaxis Master can 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
The AIRFLOW Prophylaxis Master is also intended for use as an air-polisher in patients suffering from periodontal disease. The AIRFLOW Prophylaxis Master is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.
The AIRFLOW One is 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 AIRFLOW One can 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
The AIRFLOW One is also intended for use as an air-polisher in patients suffering from periodontal disease. The AIRFLOW One is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190124: EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190124
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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