510(k) · Cleared
ClearedBeta-Powder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainbase Corporation · KOJ Airbrush
Cleared on Feb 16, 2007 as substantially equivalent to K021450 (3M Espe AG Dental Products, 2002) and 1 other predicate after a 114-day review. Its family tree reaches back 4 generations to 1987.
- Decided
- Feb 16, 2007
- Review
- 114 days
- Class
- Class II
- Product code
- KOJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K864996 (1987). No later device cites it as a predicate yet.
- Root · 4 generations backK864996 Ultrasonic Scaler 3000/ Prophy-Jet 30/ Cavi-Jet 30Dentsply Intl. · 1987
- 3 generations backK970342 Cavitron Jet with SPS SystemDentsply Intl. · 1997
- 2 generations backK014188 New Prophy PowderDentsply Intl. · 2002
- 1 generation backK021450 Clinpro Prophy Powder3M Espe AG Dental Products · 2002
- This deviceK063236 Beta-PowderBrainbase Corporation · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K864996 | Ultrasonic Scaler 3000/ Prophy-Jet 30/ Cavi-Jet 30 | Dentsply Intl. | 1987 | — |
| −3 | K970342 | Cavitron Jet with SPS System | Dentsply Intl. | 1997 | — |
| −2 | K014188 | New Prophy Powder | Dentsply Intl. | 2002 | — |
| −1 | K021450 | Clinpro Prophy Powder | 3M Espe AG Dental Products | 2002 | — |
| 0 (this device) | K063236 | Beta-Powder | Brainbase Corporation | 2007 | — |
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? (2)
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 |
|---|---|---|---|
| * | K021450 | Clinpro Prophy PowderSummary page 1…Substantial Equivalence: 13 - Powder is intended for use as a polishing or prophy powder. This use is the same as that for Clinpro Prophy Powder, cleared in K021450 by 3M Espe Dental Products, and New Prophy Powder, cleared in K014188 by Dentsply, Intl. The materials are… | 2002 |
| * | K014188 | New Prophy PowderSummary page 1…hy powder. This use is the same as that for Clinpro Prophy Powder, cleared in K021450 by 3M Espe Dental Products, and New Prophy Powder, cleared in K014188 by Dentsply, Intl. The materials are the same or similar to those that have been used in commercially marke… | 2002 |
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 20 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All KOJ devicesKOJ Airbrush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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, polishing and restoring natural esthetics of tooth enamel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063236 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063236: Beta-Powder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063236
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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