SYNTEC ORTHODONTIC MINI SCREW— 510(k) K090476

Substantially Equivalent

Syntec Scientific Corp.

FDA 510(k) clearance K090476 for SYNTEC ORTHODONTIC MINI SCREW, Substantially Equivalent on 2009-06-18. Applicant: Syntec Scientific Corp..

Clearance details

Applicant: Syntec Scientific Corp.
Product code: Code OAT
Advisory panel: Dental
Date received: 2009-02-24
Decision date: 2009-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei City, 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.