510(k) · Cleared
ClearedMicrojet Cavity Preparation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Midwest Dental Products Corp. · KOJ Airbrush
Cleared on Sep 11, 1997 after a 288-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 11, 1997
- Review
- 288 days
- Class
- Class II
- Product code
- KOJ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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?
MicroJet System is an AC-powered cavity preparation device. The device uses air-driven particles to roughen the surfaces of dental restorations.
MicroJet System is intended as an ancillary device for removing tooth structure, and restorative dental materials as well as preparing teeth for dental restoration.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964755 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964755: Microjet Cavity Preparation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964755
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026