510(k) · Cleared
ClearedMicroprep Cavity Preperation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunrise Technologies, Inc. · KOJ Airbrush
Cleared on Apr 25, 1994 after a 311-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Apr 25, 1994
- Review
- 311 days
- Class
- Class II
- Product code
- KOJ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 4 citing it directly.
- This deviceK932997 Microprep Cavity Preperation SystemSunrise Technologies, Inc. · 1994
- Descendant · cites it directly · 2 of its ownK980216 Kreativ Mach 5, Mach 5 Plus, Mach M, Mach 6Kreativ, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK990060 MACH 7Kreativ, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK984415 S.S. White Technologies, Models 6500-D,6500-E, and 6500-FS.S. White Technologies, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK955050 Jetstream Cavity Preparation SystemDove Systems, Inc. · 1996
Most influential descendants
Showing 4 of 4 · See all- K980216Kreativ Mach 5, Mach 5 Plus, Mach M, Mach 6Kreativ, Inc. · 1998 · cites it directly2descendants
- K990060MACH 7Kreativ, Inc. · 2000 · cites it directly0descendants
- K984415S.S. White Technologies, Models 6500-D,6500-E, and 6500-FS.S. White Technologies, Inc. · 1999 · cites it directly0descendants
- K955050Jetstream Cavity Preparation SystemDove Systems, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K932997 | Microprep Cavity Preperation System | Sunrise Technologies, Inc. | 1994 | — |
| +1 | K980216 | Kreativ Mach 5, Mach 5 Plus, Mach M, Mach 6 | Kreativ, Inc. | 1998 | — |
| +1 | K990060 | MACH 7 | Kreativ, Inc. | 2000 | — |
| +1 | K984415 | S.S. White Technologies, Models 6500-D,6500-E, and 6500-F | S.S. White Technologies, Inc. | 1999 | — |
| +1 | K955050 | Jetstream Cavity Preparation System | Dove Systems, Inc. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
4 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?
- Of its descendants, K980216 (Kreativ, Inc., 1998) has gone furthest, with 2 descendants of its own.
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 | — |
https://510kreport.com/device/K932997 · printed Nov 4, 2026
Cite this page
510(k) Report. “K932997: Microprep Cavity Preperation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K932997
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026