# DZI: Drill, Bone, Powered

- Device class: 2; regulation: 21 CFR 872.4120; FDA's rule: 510(k) required
- FDA decisions: 50
- 510(k) review time 2021–2025: median 62 days (middle half 3–132)
- Recalls: 6 (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)
- 2012: 4
- 2014: 1
- 2015: 3
- 2016: 1
- 2018: 3
- 2020: 3
- 2023: 1
- 2024: 2
- 2025: 1
- 2026: 2

## Most-cited predicates
- K991696: Stryker Hermes-Ready Total Performance System (1999), cited by 6
- K043408: Piezosurgery Device (2005), cited by 5
- K122322: Piezosurgery Touch (2012), cited by 4
- K032117: Stryker Total Performance (TPS) System (2003), cited by 4
- K082649: Synthes 90 Degree Screwdriver (2009), cited by 3
- K060274: Piezotome (2006), cited by 3
- K151248: Piezosurgery White (2015), cited by 2
- K091252: Implant Center 2 (2009), cited by 2
- K082532: Straumann Guided Instruments (2008), cited by 2
- K954690: Stryker Oral Max System (1996), cited by 2

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