FDA Product Code DYW: Bracket, Plastic, Orthodontic
Leading manufacturers include Ec Certification Service GmbH and Ortho Organizers, Inc..
FDA 510(k) Cleared Bracket, Plastic, Orthodontic Devices (Product Code DYW)
About Product Code DYW - Regulatory Context
510(k) Submission Activity
42 total 510(k) submissions under product code DYW since 1978, with 42 receiving FDA clearance (average review time: 118 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under DYW have taken an average of 47 days to reach a decision - down from 121 days historically, suggesting improved FDA processing for this classification.
DYW devices are reviewed by the Dental panel. Browse all Dental devices →