# LFD: Saliva, Artificial

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 51
- 510(k) review time 2021–2025: median 107 days (middle half 87–119)
- Recalls: 4 (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)
- 2015: 5
- 2017: 3
- 2018: 5
- 2019: 3
- 2020: 1
- 2021: 2
- 2023: 1
- 2024: 2
- 2025: 1
- 2026: 1

## Most-cited predicates
- K123731: Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing Mouth Spray (2013), cited by 9
- K981693: Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer Model Number 0386-000-25 (2001), cited by 8
- K061331: Oral Balance Liquid/ Gel (2006), cited by 8
- K991938: Caphosol Artificial Saliva (1999), cited by 8
- K030802: Caphosol (2003), cited by 7
- K024148: Salinum, Orclair (2003), cited by 7
- K051812: Tgo Spray (2005), cited by 4
- K101477: Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth Mouthwash (2010), cited by 3
- K072306: Bioxtra Moisturizing Gel (2007), cited by 2
- K111250: Dry Mouth Mouthwash (2012), cited by 2

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