# ELC: Scaler, Ultrasonic

- Device class: 2; regulation: 21 CFR 872.4850; FDA's rule: 510(k) required
- FDA decisions: 195
- 510(k) review time 2021–2025: median 222 days (middle half 106–268)
- 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: 2
- 2018: 1
- 2019: 4
- 2020: 1
- 2021: 3
- 2022: 2
- 2023: 5
- 2024: 4
- 2025: 2
- 2026: 2

## Most-cited predicates
- K050895: Surpasson P5 Newtron (2005), cited by 7
- K093000: Ems Piezon Master 700 (2010), cited by 7
- K953026: Minipiezon (1995), cited by 6
- K110173: Ems Air-Flow Master Piezon (2011), cited by 6
- K961158: Suprasson P5 Booster (1996), cited by 6
- K022328: Ems Piezon Master 600 (2002), cited by 5
- K960889: Sapphire Plus Scaler Mod. 300114/Plugger Mod. 300115/Cutting Mod. 300116/Spreader Mod. 300117 Tips (1996), cited by 5
- K033764: SP Newtron Module (2004), cited by 5
- K900709: Air Flow Sii (1990), cited by 4
- K081268: Sonic Air MM1500 + (Mid), Model 50400014 (2009), cited by 3

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