510(k) · Cleared
ClearedProsmile Air Polisher and Prophylaxis Powder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sirona Dental Systems GmbH · KOJ Airbrush
Cleared on Jan 15, 2004 as substantially equivalent to K022119 (Electro Medical Systems SA, 2002) after a 52-day review. Its family tree reaches back 3 generations to 1990. 1 later device descends from it.
- Decided
- Jan 15, 2004
- Review
- 52 days
- Class
- Class II
- Product code
- KOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K900709 (1990). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK900709 Air Flow SiiElectro Medical Systems (Ems Sa) · 1990
- 2 generations backK991857 Airflow HandyElectro Medical Systems, Inc. · 1999
- 1 generation backK022119 Ems Air-Flow Handy 2 Dental HandpieceElectro Medical Systems SA · 2002
- This deviceK033675 Prosmile Air Polisher and Prophylaxis PowderSirona Dental Systems GmbH · 2004
- Descendant · cites it directly · 0 of its ownK042872 Rondoflex Plus 360Kavo America Corporation · 2004
Most influential descendants
Showing 1 of 1 · See all- K042872Rondoflex Plus 360Kavo America Corporation · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K900709 | Air Flow Sii | Electro Medical Systems (Ems Sa) | 1990 | — |
| −2 | K991857 | Airflow Handy | Electro Medical Systems, Inc. | 1999 | — |
| −1 | K022119 | Ems Air-Flow Handy 2 Dental Handpiece | Electro Medical Systems SA | 2002 | — |
| 0 (this device) | K033675 | Prosmile Air Polisher and Prophylaxis Powder | Sirona Dental Systems GmbH | 2004 | — |
| +1 | K042872 | Rondoflex Plus 360 | Kavo America Corporation | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 KOJ? 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 KOJ device
- #1 K251425 turbodent touchscore 11.1 · 7 generations · no Class I recall
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 |
|---|---|---|---|
| * | K022119 | Ems Air-Flow Handy 2 Dental HandpieceSummary page 1…Air Polisher, Abrasive Polishing Agent Classification Name: Air Brush 3. Predicate Devices FMS Air Flow Handy 2Air Polisher and Powder, K022 119 4. INTENDED USE The ProSmile Air Polisher is intended for removing deposits. plaque, and staining on all vis… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042872 | Rondoflex Plus 360 | 2004 | 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 14 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K042872 (Kavo America Corporation, 2004) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K022119.
How does its category compare?
All KOJ devicesKOJ Airbrush: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KOJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KOJ
Too few KOJ 510(k)s in any year since 2007 to give a median.
Recalls per year · KOJ
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KOJ
2in 2025
MAUDE reports naming product code KOJ, 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 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 1 | 3 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ProSmile Air Polisher is intended for removing deposits, plaque, and staining on all visible tooth surfaces as well as in fissures and interdental areas. The ProSmile is also intended for the following prophylactic applications:
* cleaning teeth prior to sealing
* cleaning teeth prior to fluoridation
* cleaning teeth prior to bleaching
* cleaning teeth prior to using bonding materials
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033675 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033675: Prosmile Air Polisher and Prophylaxis Powder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033675
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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