# EFB: Handpiece, Air-Powered, Dental

- Device class: 1; regulation: 21 CFR 872.4200; FDA's rule: 510(k) required
- FDA decisions: 263
- 510(k) review time 2021–2025: median 218 days (middle half 124–430)
- Recalls: 5 (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)
- 2017: 7
- 2018: 3
- 2019: 3
- 2020: 5
- 2021: 2
- 2022: 5
- 2023: 4
- 2024: 5
- 2025: 1
- 2026: 4

## Most-cited predicates
- K070663: A-Dec/W&H Synea Air-Driven Highspeed Handpiece, Model TA-98, TA-97,  a-Dec/W&H Synea Handpiece Attachment (2007), cited by 7
- K082791: Ems Air-Flow Master (2009), cited by 6
- K052822: Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202 (2006), cited by 6
- K863677: Tradition High Speed Handpiece (1986), cited by 5
- K073478: Supertorque High-Speed Handpieces and Gentlepower Handpieces and Attachements (2008), cited by 5
- K022119: Ems Air-Flow Handy 2 Dental Handpiece (2002), cited by 5
- K062740: Jindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MU (2006), cited by 4
- K983183: Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora, Aquilon, MC2,MC3, Basch, Isolite, Optima, US, Plpe, CA, P (1998), cited by 4
- K152146: High Speed Handpieces and Accessories (2015), cited by 4
- K073284: Air-Flow Master Standard (2007), cited by 4

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