FDA Product Code OAT: Implant, Endosseous, Orthodontic
It Is Intended To Provide A Fixed Anchorage Point For Attachment Of Orthodontic Appliances To Facilitate The Orthodontic Movement Of Teeth. It Is Used Temporarily And Is Removed After Orthodontic Treatment Has Been Completed.
Leading manufacturers include Osteonic Co., Ltd., Proimtech Saglik Urunleri Anonim Sirketi and Techwin Co., Ltd..
FDA 510(k) Cleared Implant, Endosseous, Orthodontic Devices (Product Code OAT)
About Product Code OAT - Regulatory Context
510(k) Submission Activity
51 total 510(k) submissions under product code OAT since 1998, with 51 receiving FDA clearance (average review time: 217 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 OAT have taken an average of 368 days to reach a decision - up from 211 days historically. Manufacturers should account for longer review timelines in current project planning.
OAT devices are reviewed by the Dental panel. Browse all Dental devices →