# NPK: Barrier, Synthetic, Intraoral

- Device class: 2; regulation: 21 CFR 872.3930; FDA's rule: 510(k) required
- FDA decisions: 31
- 510(k) review time 2021–2025: median 520 days (middle half 267–529)
- 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)
- 2009: 1
- 2010: 2
- 2011: 1
- 2013: 1
- 2015: 2
- 2016: 1
- 2017: 1
- 2021: 1
- 2022: 1
- 2023: 3

## Most-cited predicates
- K960724: Bio-Gide Resorbable Bilayer Membrane (1997), cited by 11
- K982865: Atrisorb Bioabsorbable Guided Tissue Regeneration (GTR) Barrier Kit (1998), cited by 4
- K955838: Atrisorb Bioabsorbable Guided Tissue Regneration (GTR) (1996), cited by 3
- K033074: Inion GTR Biodegradable Membrane System (2004), cited by 3
- K143327: Neoss Ti Reinforced Membrane (2015), cited by 2
- K922627: Gore-Tex Regenerative Material (1994), cited by 2
- K051267: Gore Resolut Regenerative Material, Gore Resolut XT Regenerative Membrane, Gore Osseoquest Regenerative Membrane (2005), cited by 2
- K960292: Gore-Tex Regenerative Material Titanium Reinforced Configurations (1996), cited by 2
- K974752: Imtec/Biobarrier Membrane (1998), cited by 2
- K935137: Tefgen-FD (1994), cited by 2

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