# NJM: Bracket, Ceramic, Orthodontic

- Device class: 2; regulation: 21 CFR 872.5470; FDA's rule: 510(k) required
- FDA decisions: 60
- 510(k) review time 2021–2025: median 30 days (middle half 1–153)
- 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)
- 2014: 1
- 2015: 3
- 2016: 3
- 2017: 3
- 2018: 4
- 2019: 6
- 2020: 2
- 2021: 1
- 2022: 2
- 2023: 5

## Most-cited predicates
- K060837: IN-Ovation C (2006), cited by 9
- K102803: Clarity Advanced Ceramic Brackets (2011), cited by 7
- K073045: Sapphire Ceramic Bracket (2007), cited by 7
- K082974: Mystique MB Ceramic Brackets (2008), cited by 4
- K081415: Damon 4CLEAR (2008), cited by 4
- K080749: Radiance (2008), cited by 4
- K042178: Orthodontic Ceramic Brackets (2004), cited by 4
- K042905: Neo-Clip Orthodontic Bracket Accessory (2004), cited by 2
- K181271: Signature Orthodontic System (2018), cited by 2
- K160615: Orthodontic Ceramic Brackets 1.1 (2016), cited by 2

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