# DYW: Bracket, Plastic, Orthodontic

- Device class: 2; regulation: 21 CFR 872.5470; FDA's rule: 510(k) required
- FDA decisions: 42
- 510(k) review time 2021–2025: median 47 days (middle half 26–69)
- Recalls: 4 (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)
- 2009: 2
- 2010: 1
- 2011: 1
- 2012: 1
- 2013: 2
- 2014: 1
- 2016: 3
- 2018: 2
- 2020: 1
- 2025: 2

## Most-cited predicates
- K082207: Orthocad IQ (2009), cited by 4
- K973776: Reflections (1997), cited by 3
- K092030: Elation MB Metal Reinforced Plastic Bracket (2009), cited by 2
- K121524: Insignia (2012), cited by 2
- K140807: Composite Orthodontic Brackets (2014), cited by 2
- K944286: Metal-Lined Transcend Ceramic Bracket (1994), cited by 2
- K160720: Carriere Motion Clear Class II (2016), cited by 1
- K123118: Insignia Digicast (2013), cited by 1
- K861965: Unitek Ceramic Bracket System (1986), cited by 1
- K053055: Orthodontic Polymer Composite Bracket (2005), cited by 1

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