# ELB: Scaler, Rotary

- Device class: 2; regulation: 21 CFR 872.4840; FDA's rule: 510(k) required
- FDA decisions: 6
- 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)
- 1979: 1
- 1983: 1
- 2001: 1
- 2011: 1
- 2012: 1
- 2017: 1

## Most-cited predicates
- K111724: Straumann Tibrush (2011), cited by 1
- K782007: Rotary Scaler (1979), cited by 1

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