FDA Product Code DYH: Adhesive, Bracket And Tooth Conditioner, Resin
Leading manufacturers include Voco GmbH, American Orthodontics Corp. and Ormco Corporation.
FDA 510(k) Cleared Adhesive, Bracket And Tooth Conditioner, Resin Devices (Product Code DYH)
About Product Code DYH - Regulatory Context
510(k) Submission Activity
192 total 510(k) submissions under product code DYH since 1976, with 192 receiving FDA clearance (average review time: 81 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 DYH have taken an average of 1 days to reach a decision - down from 81 days historically, suggesting improved FDA processing for this classification.
DYH devices are reviewed by the Dental panel. Browse all Dental devices →