510(k) · Cleared
ClearedAir-N-GO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Satelec · EFB Handpiece, Air-Powered, Dental
Cleared on Dec 8, 2011 as substantially equivalent to K092289 (E.M.S Electro Medical Systems S.A, 2009) and 2 other predicates after a 301-day review. Its family tree reaches back 4 generations to 1990. 3 later devices descend from it.
- Decided
- Dec 8, 2011
- Review
- 301 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K900709 (1990). 7 ancestors in all. 3 later devices descend from it, 2 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 deviceK110379 Air-N-GOSatelec · 2011
- Descendant · cites it directly · 1 of its ownK140684 Clinpro Prophy Powder3M Deutschland GmbH · 2014
- Descendant · 2 generations on · 0 of its ownK151748 Clean & More3M Deutschland GmbH · 2016
- Descendant · cites it directly · 0 of its ownK130862 Cavitron Prophy-Jet Air Polishing Prophylaxis SystemDentsply Intl., Inc. · 2013
Most influential descendants
Showing 3 of 3 · See allView 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) | K110379 | Air-N-GO | Satelec | 2011 | — |
| +1 | K140684 | Clinpro Prophy Powder | 3M Deutschland GmbH | 2014 | — |
| +2 | K151748 | Clean & More | 3M Deutschland GmbH | 2016 | — |
| +1 | K130862 | Cavitron Prophy-Jet Air Polishing Prophylaxis System | Dentsply Intl., Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K092289 | Ems Air-Flow Handy PerioSummary page 1…SYSTEMS MEDICAL SYSTEMS ______SA SA SA K number K092289 K022119 K082791 March 09, 2011 Version 4 === Page 2 ==… | 2009 |
| * | K022119 | Ems Air-Flow Handy 2 Dental HandpieceSummary page 1…DICAL SYSTEMS ______SA SA SA K number K092289 K022119 K082791 March 09, 2011 Version 4… | 2002 |
| * | K082791 | Ems Air-Flow MasterSummary page 1…______SA SA SA K number K092289 K022119 K082791 March 09, 2011 Version 4… | 2009 |
What descends from it? (3)
2 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?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 7.2 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K140684 (3M Deutschland GmbH, 2014) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K092289.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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-N-GO by SATELEC in supra-gingival configuration is intended for use in the polishing and cleaning of teeth by the projection of a mixture of dental powder, air, water on teeth surfaces. The device can remove soft deposits and areas of discoloration and can be used to prepare teeth for conventional dental procedures such as the placement of composite fillings, porcelain inlays, and laminate veneers... The device can be used to clean implant…
Read the full statement (151 words)
The AIR-N-GO by SATELEC in supra-gingival configuration is intended for use in the polishing and cleaning of teeth by the projection of a mixture of dental powder, air, water on teeth surfaces. The device can remove soft deposits and areas of discoloration and can be used to prepare teeth for conventional dental procedures such as the placement of composite fillings, porcelain inlays, and laminate veneers... The device can be used to clean implant abutments and to clean teeth prior to treatments such as shade matching, fluoridation, and bleaching. The device can be used to d.0grease crowns and bridges prior to placement and clean fixed bands and brackets on orthodontic appliances.
The AIR-N-GO by SATELEC in sub-gingival configuration (with PERIO kit) is intended for patients suffering from periodontitis and peri-implantitis and it is indicated for the non-surgical removal of sub-gingival plaque in pockets up to 5 mm after an initial periodontal treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110379 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110379: Air-N-GO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110379
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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