# KOJ: Airbrush

- Device class: 2; regulation: 21 CFR 872.6080; FDA's rule: 510(k) required
- FDA decisions: 48
- 510(k) review time 2021–2025: median 1 days (middle half 1–1)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1997: 4
- 1998: 6
- 1999: 2
- 2000: 4
- 2001: 4
- 2002: 6
- 2003: 2
- 2004: 3
- 2007: 1
- 2025: 1

## Most-cited predicates
- K921748: Model 2000 Dental Air Abrasive System (1992), cited by 4
- K932997: Microprep Cavity Preperation System (1994), cited by 4
- K940776: Kreativ Model KV-1 (1994), cited by 3
- K902836: Microetcher (1990), cited by 2
- K002708: Kavo Corund Handpiece 2013 (2000), cited by 2
- K014188: New Prophy Powder (2002), cited by 2
- K980216: Kreativ Mach 5, Mach 5 Plus, Mach M, Mach 6 (1998), cited by 2
- K033675: Prosmile Air Polisher and Prophylaxis Powder (2004), cited by 1
- K021450: Clinpro Prophy Powder (2002), cited by 1
- K981564: Air Techniques' Airdent II (1998), cited by 1

Source page: https://510kreport.com/product-code/KOJ
Data by year (CSV): https://510kreport.com/product-code/KOJ.csv