510(k) · Cleared
ClearedEms Air-Flow Master Piezon
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 Apr 7, 2011 as substantially equivalent to K093000 (E.M.S Electro Medical Systems S.A, 2010) and 5 other predicates after a 77-day review. Its family tree reaches back 4 generations to 1990. 13 later devices descend from it.
- Decided
- Apr 7, 2011
- Review
- 77 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K900709 (1990). 14 ancestors in all. 13 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK900709 Air Flow SiiElectro Medical Systems (Ems Sa) · 1990
- 3 generations backK991857 Airflow HandyElectro Medical Systems, Inc. · 1999
- 2 generations backK022119 Ems Air-Flow Handy 2 Dental HandpieceElectro Medical Systems SA · 2002
- 1 generation backK092289 Ems Air-Flow Handy PerioE.M.S Electro Medical Systems S.A · 2009
- This deviceK110173 Ems Air-Flow Master PiezonE.M.S Electro Medical Systems S.A · 2011
- Descendant · cites it directly · 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 · 2 generations on · 2 of its ownK151912 AIR-FLOW handy 3.0 PLUSE.M.S Electro Medical Systems S.A · 2016
- Descendant · 2 generations on · 1 of its ownK231391 Combi TouchMectron S.P.A. · 2023
- Descendant · 2 generations on · 0 of its ownK260773 Varios Combi Pro2Nakanishi, Inc. · 2026
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K190124EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneE.M.S Electro Medical Systems S.A · 2019 · cites it directly4descendants
- K132478Air-Flow Handy 3.0E.M.S Electro Medical Systems S.A · 2014 · cites it directly3descendants
- K151912AIR-FLOW handy 3.0 PLUSE.M.S Electro Medical Systems S.A · 2016 · 2 generations on2descendants
- K231391Combi TouchMectron S.P.A. · 2023 · 2 generations on1descendant
- K260773Varios Combi Pro2Nakanishi, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K900709 | Air Flow Sii | Electro Medical Systems (Ems Sa) | 1990 | — |
| −3 | K991857 | Airflow Handy | Electro Medical Systems, Inc. | 1999 | — |
| −2 | 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 | — |
| 0 (this device) | K110173 | Ems Air-Flow Master Piezon | E.M.S Electro Medical Systems S.A | 2011 | — |
| +1 | 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 | — |
| +2 | K151912 | AIR-FLOW handy 3.0 PLUS | E.M.S Electro Medical Systems S.A | 2016 | — |
| +2 | K231391 | Combi Touch | Mectron S.P.A. | 2023 | — |
| +2 | K260773 | Varios Combi Pro2 | Nakanishi, Inc. | 2026 | — |
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 |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 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 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? (6)
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 |
|---|---|---|---|
| * | K093000 | Ems Piezon Master 700Summary page 1…R-FLOW MASTER PIEZON is substantially equivalent to the following legally marketed medical devices: * E.M.S. Electro Medical Systems S.A., PIEZON MASTER 700 (K093000) a E.M.S. Electro Medical Systems S.A.,AIR-FLOW HANDY PERIO (K092289) *E.M.S. Electro Medical Systems S.A., AIR-FLOW… | 2010 |
| * | K092289 | Ems Air-Flow Handy PerioSummary page 1…lly marketed medical devices: * E.M.S. Electro Medical Systems S.A., PIEZON MASTER 700 (K093000) a E.M.S. Electro Medical Systems S.A.,AIR-FLOW HANDY PERIO (K092289) *E.M.S. Electro Medical Systems S.A., AIR-FLOW MASTER (K082791) * E.M.S. Electro Medical Systems S.A., AIR-FLOW MASTE… | 2009 |
| * | K082791 | Ems Air-Flow MasterSummary page 1…S.A., PIEZON MASTER 700 (K093000) a E.M.S. Electro Medical Systems S.A.,AIR-FLOW HANDY PERIO (K092289) *E.M.S. Electro Medical Systems S.A., AIR-FLOW MASTER (K082791) * E.M.S. Electro Medical Systems S.A., AIR-FLOW MASTER STANDARD (K073284) * E.M.S. Electra Medical Systems S.A… | 2009 |
| * | K073284 | Air-Flow Master StandardSummary page 1…HANDY PERIO (K092289) *E.M.S. Electro Medical Systems S.A., AIR-FLOW MASTER (K082791) * E.M.S. Electro Medical Systems S.A., AIR-FLOW MASTER STANDARD (K073284) * E.M.S. Electra Medical Systems S.A., AIR-FLOW S2 (K900709) * E.M.S. Electro Medical Systems S.A., miniMaster LED (K0… | 2007 |
| * | K900709 | Air Flow SiiSummary page 1…AIR-FLOW MASTER (K082791) * E.M.S. Electro Medical Systems S.A., AIR-FLOW MASTER STANDARD (K073284) * E.M.S. Electra Medical Systems S.A., AIR-FLOW S2 (K900709) * E.M.S. Electro Medical Systems S.A., miniMaster LED (K093723) The instruments used with the AIR-FLOW MASTER PIEZON… | 1990 |
| * | K093723 | Ems Minimaster LedSummary page 1…AIR-FLOW MASTER STANDARD (K073284) * E.M.S. Electra Medical Systems S.A., AIR-FLOW S2 (K900709) * E.M.S. Electro Medical Systems S.A., miniMaster LED (K093723) The instruments used with the AIR-FLOW MASTER PIEZON were previously cleared by FDA: ELECTRO MEDICAL SYSTEMS SA 5… | 2010 |
What descends from it? (13)
See all 136 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190124 | EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One | 2019 | 4 |
| K132478 | Air-Flow Handy 3.0 | 2014 | 3 |
| K203615 | Dental Scaler and Air Polisher | 2021 | 0 |
| K171189 | AIR-FLOW PLUS Prophylaxis powder | 2017 | 0 |
| K130137 | Biosonic Suvi Piezeoelectric Scaler and Polisher | 2013 | 0 |
| K130862 | Cavitron Prophy-Jet Air Polishing Prophylaxis System | 2013 | 0 |
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 21 years and passes through 4 companies; a new generation was cleared every 7.2 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K190124 (E.M.S Electro Medical Systems S.A, 2019) has gone furthest, with 4 descendants of its own.
- 6 other devices also cite its predicate K093000.
How does its category compare?
All ELC devicesELC Scaler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 AIR-FLOW MASTER PIEZON combines the functions of an ultrasonic scaler and air-polishing unit within a single chassis. The AIR-FLOW MASTER PIEZON 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…
Read the full statement (254 words)
The AIR-FLOW MASTER PIEZON combines the functions of an ultrasonic scaler and air-polishing unit within a single chassis. The AIR-FLOW MASTER PIEZON 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 AIR-FLOW MASTER PIEZON 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 AIR-FLOW MASTER PIEZON 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 AIR-FLOW MASTER PIEZON is also intended for use as an air-polisher in patients suffering from periodontal disease. The AIR-FLOW MASTER PIEZON 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/K110173 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110173: Ems Air-Flow Master Piezon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110173
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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