FDA Product Code LFD: Saliva, Artificial
Leading manufacturers include Oxy2plus, LLC, The Procter & Gamble Company and Gurunanda, LLC.
FDA 510(k) Cleared Saliva, Artificial Devices (Product Code LFD)
About Product Code LFD - Regulatory Context
510(k) Submission Activity
50 total 510(k) submissions under product code LFD since 1981, with 50 receiving FDA clearance (average review time: 182 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 3 in the prior period.
FDA Review Time
Recent submissions under LFD have taken an average of 95 days to reach a decision - down from 185 days historically, suggesting improved FDA processing for this classification.
LFD devices are reviewed by the Dental panel. Browse all Dental devices →