510(k) · Cleared
ClearedRondoflex Plus 360
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kavo America Corporation · KOJ Airbrush
Cleared on Nov 23, 2004 as substantially equivalent to K002708 (Kavo America, 2000) and 2 other predicates after a 36-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Nov 23, 2004
- Review
- 36 days
- Class
- Class II
- Product code
- KOJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K900709 (1990). 7 ancestors in all. No later device cites it as a predicate yet.
- 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 backK033675 Prosmile Air Polisher and Prophylaxis PowderSirona Dental Systems GmbH · 2004
- This deviceK042872 Rondoflex Plus 360Kavo America Corporation · 2004
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 | K033675 | Prosmile Air Polisher and Prophylaxis Powder | Sirona Dental Systems GmbH | 2004 | — |
| 0 (this device) | K042872 | Rondoflex Plus 360 | Kavo America Corporation | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 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? (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 |
|---|---|---|---|
| * | K002708 | Kavo Corund Handpiece 2013Summary page 1…us 360 Handpiece Classification Name: Airbrush Product Codes KOJ Common/Usual Name: Airbrush 2. Equivalent legally marketed device: KaVo Corund Handpiece 2013 (K002708); Velopex Aquacut Fluid Abrasion Unit (K024105) and Sirona Dental Systems Prosmile Air Polisher and Prophylaxis Powder (K03… | 2000 |
| * | K024105 | Velopex Aquacut Fluid Abrasion UnitSummary page 1…Product Codes KOJ Common/Usual Name: Airbrush 2. Equivalent legally marketed device: KaVo Corund Handpiece 2013 (K002708); Velopex Aquacut Fluid Abrasion Unit (K024105) and Sirona Dental Systems Prosmile Air Polisher and Prophylaxis Powder (K033675). The latter two units use water with the air… | 2003 |
| * | K033675 | Prosmile Air Polisher and Prophylaxis PowderSummary page 1…device: KaVo Corund Handpiece 2013 (K002708); Velopex Aquacut Fluid Abrasion Unit (K024105) and Sirona Dental Systems Prosmile Air Polisher and Prophylaxis Powder (K033675). The latter two units use water with the airbrush.. 3. Indications for Use (intended use): The KaVo RONDOflex® plus 360 Handpie… | 2004 |
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 14 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K002708.
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 KaVo RONDOflex® plus 360 Handpiece is intended for the:
preparation for fissure sealing by cleaning, opening, and extending the fissures;
creation of micro-mechanical retention for adhesive restorations on enamel and dentine with subsequent acid etch technique;
preparation-of small carious defects;
removal of deep discolorations in the enamel;
cleaning and removal of adhesive residues from bridges, crowns, etc.; and,
preparation of adhesive surfaces of brackets.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042872 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042872: Rondoflex Plus 360.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042872
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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