# NUN: Bone Grafting Material, Human Source

- Device class: 2; regulation: 21 CFR 872.3930; FDA's rule: 510(k) required
- FDA decisions: 15
- 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)
- 2005: 3
- 2006: 3
- 2007: 1
- 2008: 4
- 2009: 1
- 2011: 1
- 2012: 1
- 2014: 1

## Most-cited predicates
- K051188: Grafton DBM (2006), cited by 5
- K043573: Dynagraft II Dental (2005), cited by 2
- K070147: Intergro Oral (2007), cited by 2
- K080462: Progenix DBM Putty (2008), cited by 2
- K060306: Accell Connexus Demineralized Bone Matrix Putty (2006), cited by 1
- K040501: DBX Demineralized Bone Matrix Putty, Paste and Mix (2005), cited by 1
- K091217: DBX Demineralized Bone Matrix Putty (2009), cited by 1
- K081950: Progenix Plus (2008), cited by 1

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