# EIA: Unit, Operative Dental

- Device class: 1; regulation: 21 CFR 872.6640; FDA's rule: 510(k) required
- FDA decisions: 286
- 510(k) review time 2021–2025: median 266 days (middle half 138–365)
- Recalls: 2 (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)
- 2016: 4
- 2017: 1
- 2018: 2
- 2019: 2
- 2020: 1
- 2022: 3
- 2023: 3
- 2024: 3
- 2025: 7
- 2026: 2

## Most-cited predicates
- K032543: Sirona Dental Systems C8+Dental Operative Unit with Accessories (2003), cited by 6
- K042759: Optima MX (2004), cited by 5
- K963778: CDR-Cam (1996), cited by 5
- K962071: Spirit S1/S2 (1996), cited by 5
- K983242: Sirona C8 Dental Operative Unit with Accessories (1998), cited by 5
- K963548: Dentapure Dental Unit Water Line Filter-Iodinated (1997), cited by 4
- K102234: A-Dec 200 Dental System (2010), cited by 4
- K930144: The Scitech One-Day Filter (1994), cited by 4
- K183347: K3 (2019), cited by 4
- K962665: A-Dec Self-Contained Water System (1996), cited by 3

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