STORM MINI SCREW— 510(k) K122069

Substantially Equivalent

Lancer Orthodontics, Inc.

FDA 510(k) clearance K122069 for STORM MINI SCREW, Substantially Equivalent on 2013-04-11. Applicant: Lancer Orthodontics, Inc..

Clearance details

Applicant: Lancer Orthodontics, Inc.
Product code: Code OAT
Advisory panel: Dental
Date received: 2012-07-16
Decision date: 2013-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vista, CA, US

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.