# OAT: Implant, Endosseous, Orthodontic

- Device class: 2; regulation: 21 CFR 872.3640; FDA's rule: 510(k) required
- FDA decisions: 52
- 510(k) review time 2021–2025: median 329 days (middle half 235–450)
- 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)
- 2017: 1
- 2018: 1
- 2019: 2
- 2020: 3
- 2021: 4
- 2022: 2
- 2023: 1
- 2024: 2
- 2025: 1
- 2026: 1

## Most-cited predicates
- K042965: Tomas Pin (2005), cited by 7
- K982509: Ortho Implant and Accessories (1998), cited by 6
- K090476: Syntec Orthodontic Mini Screw (2009), cited by 6
- K062733: Tomas Pin SD 6, 8, and 10 MM (2006), cited by 3
- K063495: C Type, CT Type, and Special Type Orthodontic Anchor Screws (2007), cited by 3
- K161335: Dual Top Screw System (2017), cited by 3
- K161197: Orthodontic Screw (2016), cited by 2
- K110392: PSM Lomas / Benefit Screws (2011), cited by 2
- K061266: Ortho Organizers Temporary Orthodontic Anchor (2006), cited by 2
- K103105: Orthodontic Screw (2011), cited by 2

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