Wire Sterilization Package with Indicators— 510(k) K143117

Substantially Equivalent

American Orthodontics

FDA 510(k) clearance K143117 for Wire Sterilization Package with Indicators, Substantially Equivalent on 2015-10-29. Applicant: American Orthodontics.

Clearance details

Applicant: American Orthodontics
Product code: Code FRG
Advisory panel: General Hospital
Date received: 2014-10-30
Decision date: 2015-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sheboygan, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRG

product code FRG

Other: 3
Total: 3

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.