# ELE: Implant, Subperiosteal

- Device class: 2; regulation: 21 CFR 872.3645; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 526 days (middle half 526–526)
- Recalls: 0 (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)
- 1980: 1
- 1984: 1
- 1986: 1
- 2022: 1

## Most-cited predicates
- K801208: Hollow Basket Titanium Dental Implant (1980), cited by 1

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