510(k) · Cleared
ClearedSiroair L Air Scaler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sirona Dental Systems GmbH · EFB Handpiece, Air-Powered, Dental
Cleared on Feb 23, 2004 as substantially equivalent to K944714 (A-Dec, Inc., 1995) after a 76-day review. Its family tree reaches back 1 generation to 1995. 3 later devices descend from it.
- Decided
- Feb 23, 2004
- Review
- 76 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944714 (1995). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK944714 W&H Corsair ScalerA-Dec, Inc. · 1995
- This deviceK033812 Siroair L Air ScalerSirona Dental Systems GmbH · 2004
- Descendant · cites it directly · 1 of its ownK080089 Sonicflex 2003 and Sonicflex Lux 2003 L with Instrument TipsSybron Dental Specialties, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK161639 Y-MICMicron Corporation · 2016
- Descendant · cites it directly · 0 of its ownK043497 Air Solfy, Models as-4H, as-4H-O, as-4H-V, as-4H-OV…J. Morita USA, Inc. · 2005
Most influential descendants
Showing 3 of 3 · See all- K080089Sonicflex 2003 and Sonicflex Lux 2003 L with Instrument TipsSybron Dental Specialties, Inc. · 2008 · cites it directly1descendant
- K161639Y-MICMicron Corporation · 2016 · 2 generations on0descendants
- K043497Air Solfy, Models as-4H, as-4H-O, as-4H-V, as-4H-OV, as-1,as-1-0,as-1-V, as-1-OVJ. Morita USA, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944714 | W&H Corsair Scaler | A-Dec, Inc. | 1995 | — |
| 0 (this device) | K033812 | Siroair L Air Scaler | Sirona Dental Systems GmbH | 2004 | — |
| +1 | K080089 | Sonicflex 2003 and Sonicflex Lux 2003 L with Instrument Tips | Sybron Dental Specialties, Inc. | 2008 | — |
| +2 | K161639 | Y-MIC | Micron Corporation | 2016 | — |
| +1 | K043497 | Air Solfy, Models as-4H, as-4H-O, as-4H-V, as-4H-OV, as-1,as-1-0,as-1-V, as-1-OV | J. Morita USA, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 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? (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 |
|---|---|---|---|
| * | K944714 | W&H Corsair ScalerSummary page 1…Common/Usual Name: Air-powered Scaler Classification Name: Dental handpiece and accessories 3. Predicate Devices W&H Corsair Scaler (K944714) 4. INTENDED USE The Sirona Dental Systems SIROAIR L Air Scaler is an air-powered scaler intended for use in cal… | 1995 |
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?
- Its one ancestor has no recall.
- Of its descendants, K080089 (Sybron Dental Specialties, Inc., 2008) has gone furthest, with 1 descendant of its own.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 SIROAIR L Air Scaler is an air-powered scaler intended for use in calculus removal
(subgingival and supragingival).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033812 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033812: Siroair L Air Scaler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033812
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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