510(k) · Cleared
ClearedNew Prophy Powder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · KOJ Airbrush
Cleared on Mar 15, 2002 as substantially equivalent to K970342 (Dentsply Intl., 1997) after an 84-day review. Its family tree reaches back 2 generations to 1987. 2 later devices descend from it.
- Decided
- Mar 15, 2002
- Review
- 84 days
- Class
- Class II
- Product code
- KOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K864996 (1987). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK864996 Ultrasonic Scaler 3000/ Prophy-Jet 30/ Cavi-Jet 30Dentsply Intl. · 1987
- 1 generation backK970342 Cavitron Jet with SPS SystemDentsply Intl. · 1997
- This deviceK014188 New Prophy PowderDentsply Intl. · 2002
- Descendant · cites it directly · 1 of its ownK021450 Clinpro Prophy Powder3M Espe AG Dental Products · 2002
- Descendant · cites it directly · 0 of its ownK063236 Beta-PowderBrainbase Corporation · 2007
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K864996 | Ultrasonic Scaler 3000/ Prophy-Jet 30/ Cavi-Jet 30 | Dentsply Intl. | 1987 | — |
| −1 | K970342 | Cavitron Jet with SPS System | Dentsply Intl. | 1997 | — |
| 0 (this device) | K014188 | New Prophy Powder | Dentsply Intl. | 2002 | — |
| +1 | K021450 | Clinpro Prophy Powder | 3M Espe AG Dental Products | 2002 | — |
| +1 | K063236 | Beta-Powder | Brainbase Corporation | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K970342 | Cavitron Jet with SPS SystemSummary page 1…20,2001 TRADE OR PROPRIETARY NAME: NEW PROPHY POWDER CLASSIFICATION NAME: Airbrush (ACCESSORY) 872.6080 PREDICATE DEVICES: Accessory to Cavitron Jet with SPS System K970342 DEVICE DESCRIPTION: NEW PROPHY POWDER is for use in DENTSPLY dental air polishing units. When the air polishing unit is in the J… | 1997 |
What descends from it? (2)
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 15 years and passes through 1 company; a new generation was cleared every 10.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K021450 (3M Espe AG Dental Products, 2002) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K970342.
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?
For use with all DENTSPLY® Cavitron™ Prophy-Jet® Systems and DENTSPLY® Cavitron-Jet™ Systems for cleaning, polishing and restoring the natural esthetics of tooth enamel.
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/K014188 · printed Nov 3, 2026
Cite this page
510(k) Report. “K014188: New Prophy Powder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K014188
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026