# EGS: Handpiece, Contra- And Right-Angle Attachment, Dental

- Device class: 1; regulation: 21 CFR 872.4200; FDA's rule: 510(k) required
- FDA decisions: 73
- 510(k) review time 2021–2025: median 151 days (middle half 90–240)
- Recalls: 1 (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)
- 2015: 3
- 2017: 2
- 2018: 1
- 2019: 3
- 2020: 1
- 2021: 1
- 2022: 4
- 2023: 1
- 2024: 1
- 2025: 2

## Most-cited predicates
- K011061: Surgical Contra-Angel Handpieces Types WS-56E,WS-75E/KM,WS-92 E/3,Surgical Straight Handpieces Types, S-9, S-10, S-11 (2001), cited by 10
- K962540: E-Type Contra Angle Nac-E (1996), cited by 5
- K972569: E-Type Speed Increaser Contra Angle, External Irrigation, Internal Irrigation (1997), cited by 3
- K132356: Sanao 200L, Sanao 40 /Sanao 40L, Sanao 10L, Sanao Psi / Sanao Pso, Sanao 40ST (2014), cited by 3
- K790722: Prophylaxis Angle (1979), cited by 3
- K060317: Anthogyr Contra Angles and Handpieces (2006), cited by 2
- K182999: General Cutting Contra Handpiece (2019), cited by 2
- K792445: MW Straight Attachment (1979), cited by 2
- K150750: Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray (2015), cited by 1
- K171436: STRONG Dental Handpieces (2018), cited by 1

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