DeviceClearance

Product code OAT— Dental

SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM

Classification name
Implant, Endosseous, Orthodontic
Device class
Class 2
Regulation
21 CFR 872.3640
Advisory panel
Dental
Total cleared
52
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code OAT under 21 CFR 872.3640, via openFDA

Market context for product code OAT

FDA has cleared 52 devices under product code OAT between 1998 and 2026, filed by 43 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code OAT

Adverse events under product code OAT

product code OAT
Injury
355
Total
355

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code OAT

Data sourced from openFDA. This site is unofficial and independent of the FDA.