# EJR: Agent, Polishing, Abrasive, Oral Cavity

- Device class: 1; regulation: 21 CFR 872.6030; FDA's rule: 510(k) exempt
- FDA decisions: 77
- 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)
- 2000: 2
- 2003: 1
- 2004: 7
- 2006: 2
- 2007: 1
- 2010: 2
- 2011: 2
- 2012: 1
- 2014: 1
- 2017: 1

## Most-cited predicates
- K024343: Butler Gum Prophy Paste with Novamin (2003), cited by 5
- K912945: Satin Prophylaxis Paste (1991), cited by 4
- K002989: Proclude (2000), cited by 3
- K000169: Nupro Prophylaxis Paste with Fluoride and Triclosan (2000), cited by 2
- K062166: Enamel Pro (2006), cited by 2
- K062502: Osspray Cleaning Compound (2006), cited by 2
- K990482: 3M Clinpro Prophy Paste, Model 12611 (1999), cited by 1
- K891536: Enamel Microabrasion Compound (1989), cited by 1
- K041371: Butler Nucare Prophylaxis Paste with Novamin (2004), cited by 1
- K940496: Prophy Paste (1994), cited by 1

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