Syntec Orthodontic Mini Screw Extended System— 510(k) K202790

Substantially Equivalent

Syntec Scientific Corporation

FDA 510(k) clearance K202790 for Syntec Orthodontic Mini Screw Extended System, Substantially Equivalent on 2021-09-17. Applicant: Syntec Scientific Corporation.

Clearance details

Applicant: Syntec Scientific Corporation
Product code: Code OAT
Advisory panel: Dental
Date received: 2020-09-22
Decision date: 2021-09-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Chang Hua, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code OAT

product code OAT

Injury: 355
Total: 355

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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