TF ROTARY NICKEL TITANIUM FILE— 510(k) K062856

Substantially Equivalent

Ormco Corp.

FDA 510(k) clearance K062856 for TF ROTARY NICKEL TITANIUM FILE, Substantially Equivalent on 2006-12-13. Applicant: Ormco Corp..

Clearance details

Applicant: Ormco Corp.
Product code: Code EKS
Advisory panel: Dental
Date received: 2006-09-25
Decision date: 2006-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newport Beach, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EKS

product code EKS

Malfunction: 1,949
Total: 1,949

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.