# NPL: Barrier, Animal Source, Intraoral

- Device class: 2; regulation: 21 CFR 872.3930; FDA's rule: 510(k) required
- FDA decisions: 57
- 510(k) review time 2021–2025: median 248 days (middle half 174–277)
- Recalls: 9 (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)
- 2016: 3
- 2017: 3
- 2018: 1
- 2019: 1
- 2020: 2
- 2021: 2
- 2022: 3
- 2023: 2
- 2024: 3
- 2025: 5

## Most-cited predicates
- K050446: Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone (2005), cited by 17
- K042197: Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration (2004), cited by 12
- K053260: Ossix -Plus (2006), cited by 9
- K011695: Collagen Dental Membrane (2001), cited by 5
- K102531: Mucograft (2010), cited by 5
- K012423: Mucograft (2003), cited by 4
- K073097: Tutodent Dental Membrane (2008), cited by 4
- K073711: Mucograft Collagen Matrix (2008), cited by 4
- K062881: Collagen Dental Menbrane - Conformable II (2006), cited by 4
- K061244: Mucograft (2006), cited by 3

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