510(k) · Cleared
ClearedGBT Machine Airflow Prophylaxis Master
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 Jan 28, 2026 as substantially equivalent to K190124 (E.M.S Electro Medical Systems S.A, 2019) after a 121-day review. Its family tree reaches back 6 generations to 1990.
- Decided
- Jan 28, 2026
- Review
- 121 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K900709 (1990). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK900709 Air Flow SiiElectro Medical Systems (Ems Sa) · 1990
- 5 generations backK991857 Airflow HandyElectro Medical Systems, Inc. · 1999
- 4 generations backK022119 Ems Air-Flow Handy 2 Dental HandpieceElectro Medical Systems SA · 2002
- 3 generations backK092289 Ems Air-Flow Handy PerioE.M.S Electro Medical Systems S.A · 2009
- 2 generations backK110173 Ems Air-Flow Master PiezonE.M.S Electro Medical Systems S.A · 2011
- 1 generation backK190124 EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneE.M.S Electro Medical Systems S.A · 2019 · Recalled
- This deviceK253254 GBT Machine Airflow Prophylaxis MasterE.M.S Electro Medical Systems S.A · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K900709 | Air Flow Sii | Electro Medical Systems (Ems Sa) | 1990 | — |
| −5 | K991857 | Airflow Handy | Electro Medical Systems, Inc. | 1999 | — |
| −4 | K022119 | Ems Air-Flow Handy 2 Dental Handpiece | Electro Medical Systems SA | 2002 | — |
| −3 | K092289 | Ems Air-Flow Handy Perio | E.M.S Electro Medical Systems S.A | 2009 | — |
| −2 | 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 |
| 0 (this device) | K253254 | GBT Machine Airflow Prophylaxis Master | E.M.S Electro Medical Systems S.A | 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 |
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 |
|---|---|---|---|
| * | K190124 | EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneSummary page 5…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code I K190124 11 AIRFLOW Prophylaxis Master… | 2019 |
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 36 years and passes through 4 companies; a new generation was cleared every 7.2 years on median.
- 1 of the 16 ancestors has a recall of any class.
- 2 other devices also cite its predicate K190124.
How does its category compare?
All ELC devicesELC Scaler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 GBT Machine AIRFLOW Prophylaxis Master combines the functions of an ultrasonic scaler and air-polishing unit within a single chassis. The GBT Machine 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 The GBT Machine AIRFLOW…
Read the full statement (243 words)
The GBT Machine AIRFLOW Prophylaxis Master combines the functions of an ultrasonic scaler and air-polishing unit within a single chassis.
The GBT Machine 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
The GBT Machine 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 GBT Machine 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 GBT Machine AIRFLOW Prophylaxis Master is also intended for use as an air-polisher in patients suffering from periodontal disease. The GBT Machine AIRFLOW Prophylaxis Master is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.
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/K253254 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253254: GBT Machine Airflow Prophylaxis Master.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253254
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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