510(k) · Cleared
ClearedClinpro Prophy Powder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Espe AG Dental Products · KOJ Airbrush
Cleared on Aug 1, 2002 as substantially equivalent to K014188 (Dentsply Intl., 2002) after an 87-day review. Its family tree reaches back 3 generations to 1987. 1 later device descends from it.
- Decided
- Aug 1, 2002
- Review
- 87 days
- Class
- Class II
- Product code
- KOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K864996 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK864996 Ultrasonic Scaler 3000/ Prophy-Jet 30/ Cavi-Jet 30Dentsply Intl. · 1987
- 2 generations backK970342 Cavitron Jet with SPS SystemDentsply Intl. · 1997
- 1 generation backK014188 New Prophy PowderDentsply Intl. · 2002
- This deviceK021450 Clinpro Prophy Powder3M Espe AG Dental Products · 2002
- Descendant · cites it directly · 0 of its ownK063236 Beta-PowderBrainbase Corporation · 2007
Most influential descendants
Showing 1 of 1 · See all- K063236Beta-PowderBrainbase Corporation · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K864996 | Ultrasonic Scaler 3000/ Prophy-Jet 30/ Cavi-Jet 30 | Dentsply Intl. | 1987 | — |
| −2 | K970342 | Cavitron Jet with SPS System | Dentsply Intl. | 1997 | — |
| −1 | K014188 | New Prophy Powder | Dentsply Intl. | 2002 | — |
| 0 (this device) | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K014188 | New Prophy PowderSummary page 1…UltrasonPc Scaler Common Name: ............................ b.II..CleaningPowder Predicate Device New Prophy Powder by Dentsply .......,K 014188 De-$.criptionfor the Premarkat Notification Clinpro Prophy Powder is classified as a class I I rnedlcal device because… | 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 |
|---|---|---|---|
| K063236 | Beta-Powder | 2007 | 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 15 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K063236 (Brainbase Corporation, 2007) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K014188.
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?
Cleaning, polishlng and restoring the natural esthetics of tooth anamal
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021450 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021450: Clinpro Prophy Powder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021450
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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