FDA product code KOJ: Airbrush
KOJ is the FDA product code for airbrush. It is a Class II device, regulated under 21 CFR 872.6080 and reviewed by the Dental panel. FDA has cleared 48 510(k) submissions under KOJ, 1 in the last five years, from 39 different applicants. The average 510(k) review took 202 days (median 138); 1 days on average over the last three years. FDA has posted 1 recall for KOJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Airbrush |
| Device class | Class II |
| Regulation | 21 CFR 872.6080 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KOJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 1 |
Compare with all 510(k) review times · Search every KOJ clearance
Top KOJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Deldent , Ltd. | 4 | 2002-02-19 |
| Kis Products | 3 | 2001-08-06 |
| Kreativ, Inc. | 3 | 2000-06-15 |
| Danville Engineering, Inc. | 2 | 1997-09-17 |
| Young Dental Manufacturing Co. 1, LLC | 2 | 1990-12-17 |
34 more applicants have KOJ clearances. See the full list in Caduvo.
Most recent KOJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251425 | Mectron S.P.A. | turbodent touch | 2025-05-09 | 1 |
| K063236 | Brainbase Corporation | BETA-POWDER | 2007-02-16 | 114 |
| K042872 | Kavo America Corporation | RONDOFLEX PLUS 360 | 2004-11-23 | 36 |
| K033675 | Sirona Dental Systems GmbH | PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER | 2004-01-15 | 52 |
| K033215 | Danville Materials, Inc. | PREPAIR | 2004-01-09 | 98 |
Recalls for KOJ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-12-13.
Frequently asked questions
What is FDA product code KOJ?
KOJ is the FDA product code for airbrush. It is a Class II device, regulated under 21 CFR 872.6080 and reviewed by the Dental panel.
What device class is KOJ?
Class II, regulation 21 CFR 872.6080. Typical premarket route: 510(k).
How long does a 510(k) take for product code KOJ?
Across 48 cleared submissions the average was 202 days from receipt to decision (median 138).
Which companies have the most KOJ clearances?
Deldent , Ltd. (4); Kis Products (3); Kreativ, Inc. (3); Danville Engineering, Inc. (2); Young Dental Manufacturing Co. 1, LLC (2).
Have KOJ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2010-12-13.
Next steps
- Run an FDA pathway report with predicate devices for product code KOJ
- Run a recall and safety report across every KOJ manufacturer
- Watch product code KOJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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