ORTRAUTEK ORTHOGNATHIC SYSTEM— 510(k) K031989

Substantially Equivalent

Tekka

FDA 510(k) clearance K031989 for ORTRAUTEK ORTHOGNATHIC SYSTEM, Substantially Equivalent on 2003-10-28. Applicant: Tekka.

Clearance details

Applicant: Tekka
Product code: Code JEY
Advisory panel: Dental
Date received: 2003-06-27
Decision date: 2003-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethesda, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JEY

product code JEY

Injury: 1,542
Malfunction: 2,292
Total: 3,834

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.